Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tra... | 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: Heart Cat... | 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: Port Tray... | 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) Loop... | 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) Nerv... | 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 | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped G... | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of... | Class II | Paragon 28, Inc. |
| Jun 8, 2026 | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Lami... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neur... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 19, 2026 | TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| May 19, 2026 | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| Apr 27, 2026 | Aligned Medical AMS16835 Fluids Kit RX | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was ... | Class II | Windstone Medical Packaging, Inc. |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
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.