Browse Device Recalls

3,282 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,282 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,282 FDA device recalls.

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DateProductReasonClassFirm
Aug 21, 2026 iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x6... The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity t... Class II SI-BONE, Inc.
Aug 12, 2026 HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL S... Due to incorrect inside packaging label for eyepiece. Class II Karl Storz Endoscopy
Aug 12, 2026 GM Helix Implant, REF: 109.984; There is a discrepancy between the product identification on the packaging and the dimensions of ... Class II Straumann USA LLC
Aug 10, 2026 Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, ... Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and... Class II Merit Medical Systems, Inc.
Aug 10, 2026 Presource Convenience Kits: 1) KIT, USGPIV , Catalog Numbe... The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... Class II Cardinal Health 200, LLC
Aug 10, 2026 Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... Class II Cardinal Health 200, LLC
Jul 31, 2026 Convenience kits CATARACT PACK DYNJ59881A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (US... The packaging may not consistently maintain sterile barrier integrity. Class II Maquet Cardiopulmonary Gmbh
Jul 31, 2026 Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 ... The packaging may not consistently maintain sterile barrier integrity. Class II Maquet Cardiopulmonary Gmbh
Jul 31, 2026 Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 ... The packaging may not consistently maintain sterile barrier integrity. Class II Maquet Cardiopulmonary Gmbh
Jul 29, 2026 AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freefle... Class II Windstone Medical Packaging, Inc.
Jul 23, 2026 Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture K... Blood culture convenience kits contain a component subject to a drug recall that due to an an ope... Class II Medical Action Industries, Inc. 306
Jul 22, 2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... Class II AVID Medical, Inc.
Jul 22, 2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... Class II AVID Medical, Inc.
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 13, 2026 GM Helix Implant, Endosseous Dental Implant Article No. 109.984 There may be a mismatch between the implant contained inside the packaging and the information de... Class II Straumann USA LLC
Jul 9, 2026 Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product... Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... Class II Henry Schein Inc.
Jul 9, 2026 Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114... Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... Class II Henry Schein Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jul 1, 2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... Class II Biomet, Inc.
Jun 30, 2026 Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 30, 2026 Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 30, 2026 Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... Potential for breach in sterile barrier of device packaging. Class II Boston Scientific Corporation
Jun 25, 2026 Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI... Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but un... Class II Micro Therapeutics, Inc.
Jun 24, 2026 Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM033... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pac... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr F... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KI... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.