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 |
|---|---|---|---|---|
| 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 12, 2026 | Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2)... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; ... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC0... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CD... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) P... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, ... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS8600... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG D... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM14... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYN... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| 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) |
| Apr 2, 2026 | Custom Convenience Kit containing recalled Medline Namic Angiographic Control... | Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to ... | Class I | Windstone Medical Packaging, Inc. |
| Mar 24, 2026 | Hintermann Series Talar Implant, Left, Size 2 REF 302112 | Through customer complaints, the ankle replacement system was found to contain incorrect devices:... | Class II | DT MedTech, LLC |
| Mar 11, 2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... | 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.