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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.