Browse Device Recalls
12 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 12 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 12 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 15, 2013 | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Inten... | Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with E... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with E... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, 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.