Browse Device Recalls

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Apr 20, 2012 Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Jul 1, 2011 Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction T... ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)... Class II Linvatec Corp. dba ConMed Linvatec
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.