Fresh Recalls

Medical device recalls — page 2

1,617 recent medical device recalls in our current data. Showing 201–400, newest first.

FDA Class II · Medical device · September 30, 2026

REF recall — DeRoyal Industries Inc

Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Company / brand: DeRoyal Industries recalls

Affected product: REF recall status

Official ID Z-3256-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Presource Convenience Kits recall — Cardinal Health 200, LLC

The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Convenience Kits recall status

Official ID Z-3255-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Presource Convenience Kits recall — Cardinal Health 200, LLC

The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Convenience Kits recall status

Official ID Z-3254-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US recall — Criticare Technologies, Inc.

Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Company / brand: Criticare Technologies recalls

Affected product: nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US recall status

Official ID Z-3253-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of t…

Company / brand: Abiomed recalls

Affected product: Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall status

Official ID Z-3251-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code recall — Becton, Dickinson and Company

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

Company / brand: Becton recalls

Affected product: ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code recall status

Official ID Z-3250-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall — Philips Ultrasound, LLC

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measure…

Company / brand: Philips Ultrasound recalls

Affected product: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall status

Official ID Z-3249-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Brand Name recall — CooperVision, Inc.

A small number of lenses within the affected lot are of the incorrect power.

Company / brand: CooperVision recalls

Affected product: Brand Name recall status

Official ID Z-3248-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector recall status

Official ID Z-3247-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall status

Official ID Z-3246-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall status

Official ID Z-3245-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Company / brand: Olympus of the Americas recalls

Affected product: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector recall status

Official ID Z-3244-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

SmartPath to dStream for 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: SmartPath to dStream for 1 recall status

Official ID Z-3243-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

MR 7700 and Upgrade to MR 7700 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: MR 7700 and Upgrade to MR 7700 recall status

Official ID Z-3242-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

MR 5300 Model Number (REF) recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: MR 5300 Model Number (REF) recall status

Official ID Z-3241-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Name (Model Number) recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Name (Model Number) recall status

Official ID Z-3240-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia Elition S and Ingenia Elition X recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Ingenia Elition S and Ingenia Elition X recall status

Official ID Z-3239-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia 3 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Ingenia 3 recall status

Official ID Z-3238-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia Ambition S and Ingenia Ambition X recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Ingenia Ambition S and Ingenia Ambition X recall status

Official ID Z-3237-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Ingenia 1 recall status

Official ID Z-3236-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Evolution upgrade 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Evolution upgrade 1 recall status

Official ID Z-3235-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva XR recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Achieva XR recall status

Official ID Z-3234-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva 3 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Achieva 3 recall status

Official ID Z-3233-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Company / brand: Philips North America recalls

Affected product: Achieva 1 recall status

Official ID Z-3232-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

VITEK 2 AST-N461 TEST KIT recall — Biomerieux Inc

The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential r…

Company / brand: Biomerieux recalls

Affected product: VITEK 2 AST-N461 TEST KIT recall status

Official ID Z-3231-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline convenience kits containing Healthmark Instrument Channel Brushes recall — Medline Industries, LP

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Healthmark Instrument Channel Brushes recall status

Official ID Z-3230-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Medline convenience kits containing Healthmark Instrument Channel Brushes recall — Medline Industries, LP

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as…

Company / brand: Medline Industries recalls

Affected product: Medline convenience kits containing Healthmark Instrument Channel Brushes recall status

Official ID Z-3229-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

SeaSpine Mariner Deformity Product Name recall — SEASPINE ORTHOPEDICS CORPORATION

The proximal thread depth of the spinal device is out of design specification.

Company / brand: SEASPINE ORTHOPEDICS recalls

Affected product: SeaSpine Mariner Deformity Product Name recall status

Official ID Z-3226-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors recall — Fresenius Medical Care Renal Therapies Group, LLC

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors recall status

Official ID Z-3225-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Nu recall — Maquet SAS

The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Company / brand: Maquet SAS recalls

Affected product: PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Nu recall status

Official ID Z-3224-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

REF recall — Ventec Life Systems, Inc.

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Company / brand: Ventec Life Systems recalls

Affected product: REF recall status

Official ID Z-3223-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

REF recall — Ventec Life Systems, Inc.

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Company / brand: Ventec Life Systems recalls

Affected product: REF recall status

Official ID Z-3222-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall — Ventec Life Systems, Inc.

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Company / brand: Ventec Life Systems recalls

Affected product: HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall status

Official ID Z-3221-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Midmark IQvitals Zone recall — Midmark Corporation

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Company / brand: Midmark recalls

Affected product: Midmark IQvitals Zone recall status

Official ID Z-3220-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Midmark IQvitals Zone recall — Midmark Corporation

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Company / brand: Midmark recalls

Affected product: Midmark IQvitals Zone recall status

Official ID Z-3219-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Midmark IQvitals Zone recall — Midmark Corporation

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Company / brand: Midmark recalls

Affected product: Midmark IQvitals Zone recall status

Official ID Z-3218-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Midmark IQvitals Zone recall — Midmark Corporation

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Company / brand: Midmark recalls

Affected product: Midmark IQvitals Zone recall status

Official ID Z-3217-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall — Olympus Corporation of the Americas

Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Company / brand: Olympus of the Americas recalls

Affected product: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall status

Official ID Z-3216-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Brand Name recall — Heidelberg Engineering GmbH

Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand m…

Company / brand: Heidelberg Engineering recalls

Affected product: Brand Name recall status

Official ID Z-3215-2026 · Official record ↗

FDA Class I · Medical device · September 30, 2026

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific Corporation

Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-th…

Company / brand: Boston Scientific recalls

Affected product: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall status

Official ID Z-3214-2026 · Official record ↗

FDA Class I · Medical device · September 30, 2026

Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Company / brand: AVID Medical recalls

Affected product: Halyard IV START KIT NON-STERILE recall status

Official ID Z-3194-2026 · Official record ↗

FDA Class I · Medical device · September 30, 2026

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc.

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly redu…

Company / brand: CooperSurgical recalls

Affected product: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall status

Official ID Z-3140-2026 · Official record ↗

FDA Class I · Medical device · September 30, 2026

INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc.

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly redu…

Company / brand: CooperSurgical recalls

Affected product: INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall status

Official ID Z-3139-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Pi-Cardia Inc recall — PI CARDIA LTD

Transfemoral catheter, positing arm may detached due to weld issue.

Company / brand: PI CARDIA recalls

Affected product: Pi-Cardia Inc recall status

Official ID Z-3213-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes recall — ICU Medical, Inc.

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, expo…

Company / brand: ICU Medical recalls

Affected product: CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes recall status

Official ID Z-3212-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Reign Medical Clench Staple System (Compression) recall — F & A Foundation

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Company / brand: F & A Foundation recalls

Affected product: Reign Medical Clench Staple System (Compression) recall status

Official ID Z-3211-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Convenience kits CATARACT PACK DYNJ59881A recall — Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…

Company / brand: Medline Industries recalls

Affected product: Convenience kits CATARACT PACK DYNJ59881A recall status

Official ID Z-3210-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A recall — Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…

Company / brand: Medline Industries recalls

Affected product: Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A recall status

Official ID Z-3209-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F recall — Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…

Company / brand: Medline Industries recalls

Affected product: Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F recall status

Official ID Z-3208-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A recall — Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…

Company / brand: Medline Industries recalls

Affected product: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A recall status

Official ID Z-3207-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3 recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3 recall status

Official ID Z-3206-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLA recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLA recall status

Official ID Z-3205-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from recall status

Official ID Z-3204-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic recall status

Official ID Z-3203-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK recall status

Official ID Z-3202-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINE recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINE recall status

Official ID Z-3201-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-8 recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-8 recall status

Official ID Z-3200-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/5 recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/5 recall status

Official ID Z-3199-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-41 recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-41 recall status

Official ID Z-3198-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNE recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNE recall status

Official ID Z-3197-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

OMNIFIT SERIES I ACET recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: OMNIFIT SERIES I ACET recall status

Official ID Z-3196-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No recall — Howmedica Osteonics Corp.

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o…

Company / brand: Howmedica Osteonics recalls

Affected product: AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No recall status

Official ID Z-3195-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Captus 4000e Thyroid Uptake System recall — Mirion Technologies (Capintec), Inc.

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Company / brand: Mirion Technologies (Capintec) recalls

Affected product: Captus 4000e Thyroid Uptake System recall status

Official ID Z-3193-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Et Control recall — Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10…

Company / brand: Datex-Ohmeda recalls

Affected product: Et Control recall status

Official ID Z-3192-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Aisys CS2 with Et Control recall — Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10…

Company / brand: Datex-Ohmeda recalls

Affected product: Aisys CS2 with Et Control recall status

Official ID Z-3191-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Aisys CS2 recall — Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10…

Company / brand: Datex-Ohmeda recalls

Affected product: Aisys CS2 recall status

Official ID Z-3190-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Aisys recall — Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10…

Company / brand: Datex-Ohmeda recalls

Affected product: Aisys recall status

Official ID Z-3189-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Boston Scientific Corporation StoneSmart Connect Console Contents recall — Boston Scientific Corporation

A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail elect…

Company / brand: Boston Scientific recalls

Affected product: Boston Scientific Corporation StoneSmart Connect Console Contents recall status

Official ID Z-3188-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3187-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3186-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3185-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3184-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3183-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

REF recall — Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

Company / brand: Stryker Sustainability Solutions recalls

Affected product: REF recall status

Official ID Z-3182-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Blood Culture Collection Venipuncture Kit 20/Cs recall — Medical Action Industries, Inc. 306

Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the componen…

Company / brand: Medical Action Industries recalls

Affected product: Blood Culture Collection Venipuncture Kit 20/Cs recall status

Official ID Z-3181-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Sam recall — embecta Medical II LLC

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Company / brand: embecta Medical II recalls

Affected product: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Sam recall status

Official ID Z-3180-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo recall — embecta Medical II LLC

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Company / brand: embecta Medical II recalls

Affected product: EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo recall status

Official ID Z-3179-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Kinos Axiom Total Ankle System with Axiom PSR recall — restor3d Inc.

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fix…

Company / brand: restor3d recalls

Affected product: Kinos Axiom Total Ankle System with Axiom PSR recall status

Official ID Z-3178-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Brand Name recall — Wilson-Cook Medical Inc.

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Company / brand: Wilson-Cook Medical recalls

Affected product: Brand Name recall status

Official ID Z-3177-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Happiest Baby recall — Happiest Baby, Inc

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Company / brand: Happiest Baby recalls

Affected product: Happiest Baby recall status

Official ID Z-3176-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Happiest Baby recall — Happiest Baby, Inc

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Company / brand: Happiest Baby recalls

Affected product: Happiest Baby recall status

Official ID Z-3175-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Brand Name recall — PTW FREIBURG

When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorr…

Company / brand: PTW FREIBURG recalls

Affected product: Brand Name recall status

Official ID Z-3174-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

GM Helix Implant recall — Straumann USA LLC

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Company / brand: Straumann USA recalls

Affected product: GM Helix Implant recall status

Official ID Z-3173-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

SunMed Tracheal Tube recall — WELL LEAD MEDICAL CO. LTD

The 6Fr suction catheter could not pass through the samples smoothly.

Company / brand: WELL LEAD MEDICAL CO recalls

Affected product: SunMed Tracheal Tube recall status

Official ID Z-3172-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Core Services Hub V8 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Core Services Hub V8 recall status

Official ID Z-3171-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Workflow Core Services V8 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Workflow Core Services V8 recall status

Official ID Z-3170-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Centricity PACS Server V7 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Centricity PACS Server V7 recall status

Official ID Z-3169-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Centricity PACS V2 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Centricity PACS V2 recall status

Official ID Z-3168-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Enterprise Archive V8 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Enterprise Archive V8 recall status

Official ID Z-3167-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Centricity Enterprise Archive V2 recall — GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be …

Company / brand: GE Healthcare recalls

Affected product: Centricity Enterprise Archive V2 recall status

Official ID Z-3166-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

NOxBOXi Nitric Oxide Delivery System recall — NOXBOX LTD

Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

Company / brand: NOXBOX recalls

Affected product: NOxBOXi Nitric Oxide Delivery System recall status

Official ID Z-3165-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Brand Name recall — Nuclein LLC

Due to a software issue

Company / brand: Nuclein recalls

Affected product: Brand Name recall status

Official ID Z-3164-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: IV Sets with drip chambers recall status

Official ID Z-3163-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: IV Sets with drip chambers recall status

Official ID Z-3162-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: IV Sets with drip chambers recall status

Official ID Z-3161-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: IV Sets with drip chambers recall status

Official ID Z-3160-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Oncology sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: Oncology sets with drip chambers recall status

Official ID Z-3159-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Oncology sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: Oncology sets with drip chambers recall status

Official ID Z-3158-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Non-Dedicated Gravity Administration Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: IV Non-Dedicated Gravity Administration Sets with drip chambers recall status

Official ID Z-3157-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Plum administration sets recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Company / brand: ICU Medical recalls

Affected product: Plum administration sets recall status

Official ID Z-3156-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Company / brand: AVID Medical recalls

Affected product: Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall status

Official ID Z-3154-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Company / brand: AVID Medical recalls

Affected product: Haylard BASIC BIOPSY TRAY recall status

Official ID Z-3153-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Company / brand: AVID Medical recalls

Affected product: Haylard CONTINUOUS NERVE BLOCK TRAY recall status

Official ID Z-3152-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Haylard 18G SINGLE SHOT EPI TRAY recall — AVID Medical, Inc.

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Company / brand: AVID Medical recalls

Affected product: Haylard 18G SINGLE SHOT EPI TRAY recall status

Official ID Z-3151-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Impella Optical Controller recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Company / brand: Abiomed recalls

Affected product: Impella Optical Controller recall status

Official ID Z-3150-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Company / brand: Abiomed recalls

Affected product: Impella Optical Controller with the below product descriptions and corresponding Product C recall status

Official ID Z-3149-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Company / brand: Abiomed recalls

Affected product: Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall status

Official ID Z-3148-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall — Bayer Medical Care, Inc.

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Company / brand: Bayer Medical Care recalls

Affected product: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall status

Official ID Z-3147-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Percutaneous Insertion Kit (PIK) recall — Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

Company / brand: Maquet Cardiopulmonary recalls

Affected product: Percutaneous Insertion Kit (PIK) recall status

Official ID Z-3146-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Percutaneous Insertion Kit (PIK) recall — Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

Company / brand: Maquet Cardiopulmonary recalls

Affected product: Percutaneous Insertion Kit (PIK) recall status

Official ID Z-3145-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Percutaneous Insertion Kit (PIK) recall — Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

Company / brand: Maquet Cardiopulmonary recalls

Affected product: Percutaneous Insertion Kit (PIK) recall status

Official ID Z-3144-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04 recall — GE Medical Systems Information Technologies Inc

Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

Company / brand: GE Medical Systems Information Technologies recalls

Affected product: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04 recall status

Official ID Z-3143-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Philips PIC iX Essentials REF recall — Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

Company / brand: Philips North America recalls

Affected product: Philips PIC iX Essentials REF recall status

Official ID Z-3142-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Philips Patient Information Center iX REF recall — Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

Company / brand: Philips North America recalls

Affected product: Philips Patient Information Center iX REF recall status

Official ID Z-3141-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Medline Convenience Kit recall — Medline Industries, LP

The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a comprom…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kit recall status

Official ID Z-3137-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

StatStrip Glucose and B- Ketone meter recall — Nova Biomedical Corporation

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode i…

Company / brand: Nova Biomedical recalls

Affected product: StatStrip Glucose and B- Ketone meter recall status

Official ID Z-3132-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

StatStrip Glucose and B- Ketone meter recall — Nova Biomedical Corporation

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode i…

Company / brand: Nova Biomedical recalls

Affected product: StatStrip Glucose and B- Ketone meter recall status

Official ID Z-3131-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

StatStrip Glucose and B- Ketone meter recall — Nova Biomedical Corporation

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode i…

Company / brand: Nova Biomedical recalls

Affected product: StatStrip Glucose and B- Ketone meter recall status

Official ID Z-3130-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

StatStrip Glucose Hospital Meter System recall — Nova Biomedical Corporation

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode i…

Company / brand: Nova Biomedical recalls

Affected product: StatStrip Glucose Hospital Meter System recall status

Official ID Z-3129-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

StatStrip Glucose Hospital Meter System recall — Nova Biomedical Corporation

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode i…

Company / brand: Nova Biomedical recalls

Affected product: StatStrip Glucose Hospital Meter System recall status

Official ID Z-3128-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3127-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3126-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3125-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3124-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3123-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3122-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3121-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Halyard IV START KIT NON-STERILE REF recall — AVID Medical, Inc.

Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

Company / brand: AVID Medical recalls

Affected product: Halyard IV START KIT NON-STERILE REF recall status

Official ID Z-3108-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusi recall — BD SWITZERLAND SARL

Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

Company / brand: BD SWITZERLAND SARL recalls

Affected product: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusi recall status

Official ID Z-3080-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

DuoGlide Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.

this is a downstream recall of class I recall RES 98777

Company / brand: Bard Access Systems recalls

Affected product: DuoGlide Short-Term Straight Dialysis Catheter recall status

Official ID Z-2985-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Power-Trialysis Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.

this is a downstream recall of class I recall RES 98777

Company / brand: Bard Access Systems recalls

Affected product: Power-Trialysis Short-Term Straight Dialysis Catheter recall status

Official ID Z-2984-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

AMS Convenience Kit recall — Windstone Medical Packaging, Inc.

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the i…

Company / brand: Windstone Medical Packaging recalls

Affected product: AMS Convenience Kit recall status

Official ID Z-3138-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Citric Complete Liquid Citric Acid Concentrate REF recall — Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

Company / brand: Nipro Renal Soultions USA recalls

Affected product: Citric Complete Liquid Citric Acid Concentrate REF recall status

Official ID Z-3136-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Citric Complete Dry Citric Acid Concentrate REF recall — Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

Company / brand: Nipro Renal Soultions USA recalls

Affected product: Citric Complete Dry Citric Acid Concentrate REF recall status

Official ID Z-3135-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

MedicaLyte Bicarbonate Powder REF recall — Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

Company / brand: Nipro Renal Soultions USA recalls

Affected product: MedicaLyte Bicarbonate Powder REF recall status

Official ID Z-3134-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

MedicaLyte Liquid Bicarbonate Concentrate REF recall — Nipro Renal Soultions USA, Corporation

Hemodialysis concentrates contain high endotoxin levels

Company / brand: Nipro Renal Soultions USA recalls

Affected product: MedicaLyte Liquid Bicarbonate Concentrate REF recall status

Official ID Z-3133-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

HeartSine SAM 350P 350P US Device recall — HeartSine Technologies Ltd

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Company / brand: HeartSine Technologies recalls

Affected product: HeartSine SAM 350P 350P US Device recall status

Official ID Z-3120-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3119-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3118-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3117-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3116-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3115-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Products that contain the Pericare Wipes recall — C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Company / brand: C.R. Bard recalls

Affected product: Products that contain the Pericare Wipes recall status

Official ID Z-3114-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Getinge PVC Thoracic Catheter recall — Atrium Medical Corporation

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Company / brand: Atrium Medical recalls

Affected product: Getinge PVC Thoracic Catheter recall status

Official ID Z-3113-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Getinge PVC Thoracic Catheter recall — Atrium Medical Corporation

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Company / brand: Atrium Medical recalls

Affected product: Getinge PVC Thoracic Catheter recall status

Official ID Z-3112-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Getinge PVC Thoracic Catheter recall — Atrium Medical Corporation

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Company / brand: Atrium Medical recalls

Affected product: Getinge PVC Thoracic Catheter recall status

Official ID Z-3111-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Product Name recall — Lutronic Corporation

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Company / brand: Lutronic recalls

Affected product: Product Name recall status

Official ID Z-3110-2026 · Official record ↗

FDA Class II · Medical device · September 16, 2026

Halyard IV Start Kit Non-Sterile REF recall — AVID Medical, Inc.

Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the …

Company / brand: AVID Medical recalls

Affected product: Halyard IV Start Kit Non-Sterile REF recall status

Official ID Z-3109-2026 · Official record ↗

FDA Class I · Medical device · September 16, 2026

Kit recall — Medical Action Industries, Inc. 306

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Company / brand: Medical Action Industries recalls

Affected product: Kit recall status

Official ID Z-3107-2026 · Official record ↗

FDA Class I · Medical device · September 16, 2026

Kit recall — Medical Action Industries, Inc. 306

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Company / brand: Medical Action Industries recalls

Affected product: Kit recall status

Official ID Z-3106-2026 · Official record ↗

FDA Class I · Medical device · September 16, 2026

Bravo CF capsule delivery device recall — Given Imaging Ltd.

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, he…

Company / brand: Given Imaging recalls

Affected product: Bravo CF capsule delivery device recall status

Official ID Z-3090-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3105-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3104-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3103-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3102-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3101-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3100-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3099-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3098-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3097-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3096-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3095-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall — Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is…

Company / brand: Cardinal Health 200 recalls

Affected product: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recall status

Official ID Z-3094-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Citrasate recall — Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: Citrasate recall status

Official ID Z-3093-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

NaturaLyte recall — Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: NaturaLyte recall status

Official ID Z-3092-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

GRANUFLO Dry Acid Concentrate recall — Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: GRANUFLO Dry Acid Concentrate recall status

Official ID Z-3091-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Brand Name recall — B Braun Medical Inc

Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

Company / brand: B Braun Medical recalls

Affected product: Brand Name recall status

Official ID Z-3089-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Velys Enabling Tech Robotic-Assist Station REF recall — Medos International Sarl

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

Company / brand: Medos International Sarl recalls

Affected product: Velys Enabling Tech Robotic-Assist Station REF recall status

Official ID Z-3088-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall — Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol…

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall status

Official ID Z-3087-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C recall — Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol…

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C recall status

Official ID Z-3086-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall — Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol…

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall status

Official ID Z-3085-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 recall — Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol…

Company / brand: Fresenius Medical Care Renal Therapies Group recalls

Affected product: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 recall status

Official ID Z-3084-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

LUX-Dx recall — Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…

Company / brand: Boston Scientific recalls

Affected product: LUX-Dx recall status

Official ID Z-3083-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

LUX-Dx recall — Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…

Company / brand: Boston Scientific recalls

Affected product: LUX-Dx recall status

Official ID Z-3082-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

LUX-Dx recall — Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…

Company / brand: Boston Scientific recalls

Affected product: LUX-Dx recall status

Official ID Z-3081-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION recall status

Official ID Z-3079-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP K recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP K recall status

Official ID Z-3078-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP D recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP D recall status

Official ID Z-3077-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981 recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981 recall status

Official ID Z-3076-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KI recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KI recall status

Official ID Z-3075-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KI recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KI recall status

Official ID Z-3074-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULT recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULT recall status

Official ID Z-3073-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KI recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KI recall status

Official ID Z-3072-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB recall status

Official ID Z-3071-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PI recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PI recall status

Official ID Z-3070-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DY recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DY recall status

Official ID Z-3069-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS98 recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS98 recall status

Official ID Z-3068-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT recall — Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT recall status

Official ID Z-3067-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Baxter Novum IQ Syringe Pump recall — Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

Company / brand: Baxter Healthcare recalls

Affected product: Baxter Novum IQ Syringe Pump recall status

Official ID Z-3066-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Baxter Novum IQ Syringe Pump recall — Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

Company / brand: Baxter Healthcare recalls

Affected product: Baxter Novum IQ Syringe Pump recall status

Official ID Z-3065-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

HEALON EndoCoat PRO recall — Johnson & Johnson Surgical Vision, Inc.

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, with…

Company / brand: Johnson & Johnson Surgical Vision recalls

Affected product: HEALON EndoCoat PRO recall status

Official ID Z-3064-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3063-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3062-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3061-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3060-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3059-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3058-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3057-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3056-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-3055-2026 · Official record ↗

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Sources last checked October 22, 2026 at 12:00 PM UTC.