Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2017 | Eye Plastic Tray, part number PSS1931(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | D & C Kit, part number CMP1466(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Custom Venous Kit, part number TVS4024(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Laparotomy Pack - NS, part number AMS4347 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic P... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | C-Tray Pack, part number PSS2707(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | General Pack, part number AMS2967(A General Pack, part number AMS3239(A Gen... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Arthroscopy Pack, part number AMS6559 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Newport Coast Basic Pack, part number 007484-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Setup Tray, part number AMS6414 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | HSG Pack, part number PSS3287 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparoscopy Pack (1184), part number AMS6562 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Total Hip Pack, part number PSS2956 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Kit, part number PHC1307(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Transvaginal Pack, part number CMP1767 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Knee Pack, part number AMS4211 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Orbitofacial Pack, part number AMS5850(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Ortho Pack, part number PSS3466(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Pack (1345), part number AMS6565 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Surgical Pack, part number PSS3540(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Minor/General/Ortho Pack, part number PSS3258(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | General Surgery Pack, part number PSS1380(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Upper Torso Tray, part number PSS1554(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Nasal Pack, part number PSS2186 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 4, 2017 | Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... | packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... | Class II | Zimmer Biomet, Inc. |
| Dec 19, 2016 | Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... | Product complaints indicated that the part and lot numbers on the packaging differed from the phy... | Class II | Zimmer Biomet, Inc. |
| Dec 19, 2016 | RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m... | Product complaints indicated that the part and lot numbers on the packaging differed from the phy... | Class II | Zimmer Biomet, Inc. |
| Dec 15, 2016 | ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 14, 2016 | 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 13, 2016 | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... | Class II | Boston Scientific Corporation |
| Dec 7, 2016 | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small S... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The prod... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem ... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
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.