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