Fresh Recalls

Medical device recalls — page 5

1,617 recent medical device recalls in our current data. Showing 801–1,000, newest first.

FDA Class II · Medical device · July 8, 2026

OTP5000 THORA/PARA TRAY recall — Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Company / brand: Bard Access Systems recalls

Affected product: OTP5000 THORA/PARA TRAY recall status

Official ID Z-2655-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number recall — BD SWITZERLAND SARL

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

Company / brand: BD SWITZERLAND SARL recalls

Affected product: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number recall status

Official ID Z-2654-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall — Covidien LLC

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Company / brand: Covidien recalls

Affected product: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall status

Official ID Z-2653-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Zeiss Intrabeam Spherical Applicator 1 recall — Carl Zeiss Meditec AG

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Company / brand: Carl Zeiss Meditec AG recalls

Affected product: Zeiss Intrabeam Spherical Applicator 1 recall status

Official ID Z-2649-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradual…

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS icono ceiling recall status

Official ID Z-2648-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

RayCare 2024A SP4 recall — RAYSEARCH LABORATORIES AB

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…

Company / brand: RAYSEARCH LABORATORIES AB recalls

Affected product: RayCare 2024A SP4 recall status

Official ID Z-2647-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

RayCare 2024A SP1 recall — RAYSEARCH LABORATORIES AB

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,…

Company / brand: RAYSEARCH LABORATORIES AB recalls

Affected product: RayCare 2024A SP1 recall status

Official ID Z-2646-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — Medela Inc

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritiona…

Company / brand: Medela recalls

Affected product: Brand Name recall status

Official ID Z-2645-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…

Company / brand: Accuray Incorporated recalls

Affected product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall status

Official ID Z-2644-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono floor recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS icono floor recall status

Official ID Z-2643-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS icono ceiling recall status

Official ID Z-2642-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

ARTIS icono biplane recall — Siemens Medical Solutions USA, Inc

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Company / brand: Siemens Medical Solutions USA recalls

Affected product: ARTIS icono biplane recall status

Official ID Z-2641-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i…

Company / brand: Accuray Incorporated recalls

Affected product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall status

Official ID Z-2640-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Brand Name recall — TELEFLEX LLC

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Company / brand: TELEFLEX recalls

Affected product: Brand Name recall status

Official ID Z-2639-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Adapter for Head Positioning recall — Baxter Healthcare Corporation

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Secti…

Company / brand: Baxter Healthcare recalls

Affected product: Adapter for Head Positioning recall status

Official ID Z-2638-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 18-20mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 18-20mm 240cm recall status

Official ID Z-2637-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 15-18mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 15-18mm 240cm recall status

Official ID Z-2636-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 12-15mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 12-15mm 240cm recall status

Official ID Z-2635-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 10-12mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 10-12mm 240cm recall status

Official ID Z-2634-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 8-10mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 8-10mm 240cm recall status

Official ID Z-2633-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Wireguided 6-8mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Wireguided 6-8mm 240cm recall status

Official ID Z-2632-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 18-20mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 18-20mm 240cm recall status

Official ID Z-2631-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 15-18mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 15-18mm 240cm recall status

Official ID Z-2630-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 12-15mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 12-15mm 240cm recall status

Official ID Z-2629-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 10-12mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 10-12mm 240cm recall status

Official ID Z-2628-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 8-10mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 8-10mm 240cm recall status

Official ID Z-2627-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

CRE Pro Wireguided 6-8mm 240cm recall — Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

Company / brand: Boston Scientific recalls

Affected product: CRE Pro Wireguided 6-8mm 240cm recall status

Official ID Z-2626-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

IntelliCuff recall — Hamilton Medical AG

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by…

Company / brand: Hamilton Medical AG recalls

Affected product: IntelliCuff recall status

Official ID Z-2625-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves Division

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedur…

Company / brand: Medtronic Heart Valves Division recalls

Affected product: Medtronic Harmony Delivery Catheter System recall status

Official ID Z-2624-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

GC Agar Base (150mm) 10/PK R04030 recall — Remel, Inc

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Company / brand: Remel recalls

Affected product: GC Agar Base (150mm) 10/PK R04030 recall status

Official ID Z-2623-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Affected product: A M S recall status

Official ID Z-2622-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Affected product: A M S recall status

Official ID Z-2621-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Affected product: A M S recall status

Official ID Z-2620-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

A M S recall — Windstone Medical Packaging, Inc.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization …

Company / brand: Windstone Medical Packaging recalls

Affected product: A M S recall status

Official ID Z-2619-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Short Monobloc Stem Broaches recall — Medacta Usa Inc

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are posit…

Company / brand: Medacta Usa recalls

Affected product: Short Monobloc Stem Broaches recall status

Official ID Z-2618-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Affected product: Depuy Synthes recall status

Official ID Z-2617-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Depuy Synthes recall — DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Company / brand: DEPUY (IRELAND) recalls

Affected product: Depuy Synthes recall status

Official ID Z-2616-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall — Medline Industries, LP

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface…

Company / brand: Medline Industries recalls

Affected product: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall status

Official ID Z-2615-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

SYRINGE LUER LOK 10CC-200/BOX BD Product Code recall — Mentor Texas LP

A single lot of expired syringes were distributed due to a distribution system control failure.

Company / brand: Mentor Texas LP recalls

Affected product: SYRINGE LUER LOK 10CC-200/BOX BD Product Code recall status

Official ID Z-2614-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS recall status

Official ID Z-2613-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall status

Official ID Z-2612-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall status

Official ID Z-2611-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET recall status

Official ID Z-2610-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ9 recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ9 recall status

Official ID Z-2609-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE recall status

Official ID Z-2608-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G recall status

Official ID Z-2607-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall — Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX recall status

Official ID Z-2606-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod (Eros) Pod recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Affected product: Omnipod (Eros) Pod recall status

Official ID Z-2605-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod DASH Pod recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Affected product: Omnipod DASH Pod recall status

Official ID Z-2604-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Omnipod 5 Pods recall — Insulet Corporation

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The p…

Company / brand: Insulet recalls

Affected product: Omnipod 5 Pods recall status

Official ID Z-2603-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Affected product: Hillrom VOLARA System P recall status

Official ID Z-2551-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Affected product: Hillrom VOLARA System P recall status

Official ID Z-2550-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Affected product: Hillrom VOLARA P recall status

Official ID Z-2549-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Hillrom VOLARA System P recall — Baxter Healthcare Corporation

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the p…

Company / brand: Baxter Healthcare recalls

Affected product: Hillrom VOLARA System P recall status

Official ID Z-2548-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2547-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2546-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2545-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2544-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2543-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2542-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2541-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2540-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2539-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2538-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2537-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2536-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2535-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2534-2026 · Official record ↗

FDA Class II · Medical device · July 8, 2026

Medline Convenience Kits recall — Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2533-2026 · Official record ↗

FDA Class I · Medical device · July 8, 2026

Breathing circuit set recall — Hamilton Medical AG

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalati…

Company / brand: Hamilton Medical AG recalls

Affected product: Breathing circuit set recall status

Official ID Z-2463-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status

Official ID Z-2602-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status

Official ID Z-2601-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Affected product: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall status

Official ID Z-2600-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Company / brand: Abiomed recalls

Affected product: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall status

Official ID Z-2599-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2596-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2595-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2594-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2593-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2592-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2591-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2590-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2589-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2588-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2587-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2586-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2585-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2584-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2583-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2582-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall — Medline Industries, LP

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Company / brand: Medline Industries recalls

Affected product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes recall status

Official ID Z-2581-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall — Boston Scientific Corporation

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Company / brand: Boston Scientific recalls

Affected product: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall status

Official ID Z-2580-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Telemetry Monitor 5500 1 recall — Philips North America Llc

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI…

Company / brand: Philips North America recalls

Affected product: Philips Telemetry Monitor 5500 1 recall status

Official ID Z-2579-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Brand Name recall — Zimmer, Inc.

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

Company / brand: Zimmer recalls

Affected product: Brand Name recall status

Official ID Z-2578-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus 4 Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Octopus 4 Tissue Stabilizer recall status

Official ID Z-2577-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus Evolution AS Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Octopus Evolution AS Tissue Stabilizer recall status

Official ID Z-2576-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Octopus Evolution Tissue Stabilizer recall — Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can…

Company / brand: Medtronic Perfusion Systems recalls

Affected product: Octopus Evolution Tissue Stabilizer recall status

Official ID Z-2575-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Brand Name recall — Dexcom, Inc.

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies …

Company / brand: Dexcom recalls

Affected product: Brand Name recall status

Official ID Z-2574-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2573-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2572-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2571-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2570-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2569-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2568-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2567-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2566-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2565-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2564-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2563-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2562-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2561-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2560-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2559-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2558-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2557-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2556-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Company / brand: SURGIFY MEDICAL OY recalls

Affected product: Surgify Halo recall status

Official ID Z-2555-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Thuvera Laser Console recall — IPG Medical Corporation

Software anomaly that causes a false display of error code 5018.

Company / brand: IPG Medical recalls

Affected product: Thuvera Laser Console recall status

Official ID Z-2554-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

GE Healthcare AW Server 3 recall — GE Medical Systems SCS

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches…

Company / brand: GE Medical Systems SCS recalls

Affected product: GE Healthcare AW Server 3 recall status

Official ID Z-2553-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

INZONE DETACHMENT SYSTEM recall — Stryker Neurovascular

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be …

Company / brand: Stryker Neurovascular recalls

Affected product: INZONE DETACHMENT SYSTEM recall status

Official ID Z-2552-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Acumed Hexalob Screw various sizes recall — Acumed LLC

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Company / brand: Acumed recalls

Affected product: Acumed Hexalob Screw various sizes recall status

Official ID Z-2532-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Alliance Glenoid recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Affected product: Off-Axis Alliance Glenoid recall status

Official ID Z-2531-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Alliance Glenoid recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Affected product: Off-Axis Alliance Glenoid recall status

Official ID Z-2530-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Comprehensive Shoulder System recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Affected product: Off-Axis Comprehensive Shoulder System recall status

Official ID Z-2529-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Comprehensive Shoulder System recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Affected product: Off-Axis Comprehensive Shoulder System recall status

Official ID Z-2528-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Off-Axis Comprehensive Shoulder System Small recall — Zimmer, Inc.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Company / brand: Zimmer recalls

Affected product: Off-Axis Comprehensive Shoulder System Small recall status

Official ID Z-2527-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Multi-Snare Set recall — PFM MEDICAL INC.

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-…

Company / brand: PFM MEDICAL recalls

Affected product: Multi-Snare Set recall status

Official ID Z-2526-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

VOCSN+Pro package recall — Ventec Life Systems, Inc.

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the back…

Company / brand: Ventec Life Systems recalls

Affected product: VOCSN+Pro package recall status

Official ID Z-2525-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

TMJ Bilateral Implants recall — TMJ Solutions Inc

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Company / brand: TMJ Solutions recalls

Affected product: TMJ Bilateral Implants recall status

Official ID Z-2524-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Avalon Fetal Monitor recall — Philips North America Llc

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…

Company / brand: Philips North America recalls

Affected product: Philips Avalon Fetal Monitor recall status

Official ID Z-2523-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Avalon Fetal Monitor recall — Philips North America Llc

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…

Company / brand: Philips North America recalls

Affected product: Philips Avalon Fetal Monitor recall status

Official ID Z-2522-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Da Vinci ASSY recall — Intuitive Surgical, Inc.

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engage…

Company / brand: Intuitive Surgical recalls

Affected product: Da Vinci ASSY recall status

Official ID Z-2521-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Medline Convenience Kits recall — Medline Industries, LP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2455-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Medline Convenience Kits recall — Medline Industries, LP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2454-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Medline Convenience Kits recall — Medline Industries, LP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2453-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Medline Convenience Kits recall — Medline Industries, LP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…

Company / brand: Medline Industries recalls

Affected product: Medline Convenience Kits recall status

Official ID Z-2452-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Brand Name recall — Thoratec LLC

Due to 11 volt Backup Battery failures.

Company / brand: Thoratec recalls

Affected product: Brand Name recall status

Official ID Z-2520-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Brand Name recall — Thoratec LLC

Due to 11 volt Backup Battery failures.

Company / brand: Thoratec recalls

Affected product: Brand Name recall status

Official ID Z-2519-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Brand Name recall — Thoratec LLC

Due to 11 volt Backup Battery failures.

Company / brand: Thoratec recalls

Affected product: Brand Name recall status

Official ID Z-2518-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Splashwire Hydrophilic Guide Wire recall — Merit Medical Systems, Inc.

Due to unsealed portions of pouches.

Company / brand: Merit Medical Systems recalls

Affected product: Splashwire Hydrophilic Guide Wire recall status

Official ID Z-2517-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Brand Name recall — Inspire Medical Systems Inc.

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D…

Company / brand: Inspire Medical Systems recalls

Affected product: Brand Name recall status

Official ID Z-2516-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Brand Name recall — Inspire Medical Systems Inc.

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D…

Company / brand: Inspire Medical Systems recalls

Affected product: Brand Name recall status

Official ID Z-2515-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code recall — BD SWITZERLAND SARL

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has …

Company / brand: BD SWITZERLAND SARL recalls

Affected product: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code recall status

Official ID Z-2514-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfu…

Company / brand: Beta Bionics recalls

Affected product: iLet Bionic Pancreas recall status

Official ID Z-2513-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Product Name recall — Staar Surgical AG

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Company / brand: Staar Surgical AG recalls

Affected product: Product Name recall status

Official ID Z-2509-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2508-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2507-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2506-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY recall status

Official ID Z-2505-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2504-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as BASIC GYN recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as BASIC GYN recall status

Official ID Z-2503-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2502-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2501-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2500-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2499-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2498-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT recall status

Official ID Z-2497-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2496-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2495-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2494-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2493-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2492-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2491-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2490-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2489-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2488-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART recall status

Official ID Z-2487-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2486-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Medical Procedure Kits labeled as recall status

Official ID Z-2485-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall status

Official ID Z-2484-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag recall status

Official ID Z-2483-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Urethral Catheterization Tray and Bag recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Urethral Catheterization Tray and Bag recall status

Official ID Z-2482-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Pre-connected Urethral Catheterization Tray and Bag recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Pre-connected Urethral Catheterization Tray and Bag recall status

Official ID Z-2481-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Urethral Catheterization Tray recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Urethral Catheterization Tray recall status

Official ID Z-2480-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

MEDLINE Urethral Catheter recall — Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…

Company / brand: Medline Industries recalls

Affected product: MEDLINE Urethral Catheter recall status

Official ID Z-2479-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Mito Red Light recall — MITO RED LIGHT INC

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

Company / brand: MITO RED LIGHT recalls

Affected product: Mito Red Light recall status

Official ID Z-2478-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Giraffe OmniBed Field Replaceable Unit (FRU) recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…

Company / brand: GE Medical Systems recalls

Affected product: Giraffe OmniBed Field Replaceable Unit (FRU) recall status

Official ID Z-2477-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1 recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…

Company / brand: GE Medical Systems recalls

Affected product: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1 recall status

Official ID Z-2476-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Giraffe OmniBed recall — GE Medical Systems, LLC

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during tr…

Company / brand: GE Medical Systems recalls

Affected product: Giraffe OmniBed recall status

Official ID Z-2475-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall status

Official ID Z-2474-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2473-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall status

Official ID Z-2472-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2471-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2470-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2469-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2468-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall status

Official ID Z-2467-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip recall status

Official ID Z-2466-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip recall status

Official ID Z-2465-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip recall — ConMed Corporation

Potential for overpressure alerts.

Company / brand: ConMed recalls

Affected product: ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip recall status

Official ID Z-2464-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

TRI TS BASEPLATE SIZE 4 recall — Howmedica Osteonics Corp.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon…

Company / brand: Howmedica Osteonics recalls

Affected product: TRI TS BASEPLATE SIZE 4 recall status

Official ID Z-2462-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

TRI TS BASEPLATE SIZE 3 recall — Howmedica Osteonics Corp.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon…

Company / brand: Howmedica Osteonics recalls

Affected product: TRI TS BASEPLATE SIZE 3 recall status

Official ID Z-2461-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

directCHECK ACT-LR whole blood quality control recall — Accriva Diagnostics, Inc.

Assayed Whole blood control contains labeling with incorrect performance range.

Company / brand: Accriva Diagnostics recalls

Affected product: directCHECK ACT-LR whole blood quality control recall status

Official ID Z-2460-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Ritmed Neurological Sponges recall — AMD Medicom Inc.

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end…

Company / brand: AMD Medicom recalls

Affected product: Ritmed Neurological Sponges recall status

Official ID Z-2459-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Ritmed Neurological Sponges recall — AMD Medicom Inc.

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet end…

Company / brand: AMD Medicom recalls

Affected product: Ritmed Neurological Sponges recall status

Official ID Z-2458-2026 · Official record ↗

FDA Class I · Medical device · June 24, 2026

Impella CP Set with SmartAssist recall — Abiomed, Inc.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Company / brand: Abiomed recalls

Affected product: Impella CP Set with SmartAssist recall status

Official ID Z-2457-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall — Smith & Nephew, Inc.

Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equ…

Company / brand: Smith & Nephew recalls

Affected product: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall status

Official ID Z-2456-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

Medtronic O-arm O2 Imaging System recall — Medtronic Navigation, Inc.-Boxborough

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

Company / brand: Medtronic Navigation recalls

Affected product: Medtronic O-arm O2 Imaging System recall status

Official ID Z-2451-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

ALYON Surgical Lighting System recall — Steris Corporation

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Company / brand: Steris recalls

Affected product: ALYON Surgical Lighting System recall status

Official ID Z-2450-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

HarmonyAIR A-Series Surgical Lighting System recall — Steris Corporation

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Company / brand: Steris recalls

Affected product: HarmonyAIR A-Series Surgical Lighting System recall status

Official ID Z-2449-2026 · Official record ↗

FDA Class II · Medical device · June 24, 2026

HarmonyAIR A-Series Surgical Lighting System recall — Steris Corporation

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Company / brand: Steris recalls

Affected product: HarmonyAIR A-Series Surgical Lighting System recall status

Official ID Z-2448-2026 · Official record ↗

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