Browse Device Recalls
8 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 8 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 8 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 4, 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is int... | Three (3) complaints were identified in which the potential for utilization of the JTS Grower Dr... | Class II | Stanmore Implants Worldwide Ltd. |
| 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. |
| Dec 7, 2016 | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste... | 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 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge 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. |
| May 31, 2016 | METS SMILES Total Knee Replacement | The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the inten... | Class II | Stanmore Implants Worldwide Ltd. |
| Apr 12, 2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant ... | Incorrect component used to manufacture distal femoral replacement. | 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.