Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
May 9, 2012 Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
Apr 20, 2012 Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... 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 A-Flex Multiple Sizes Grafton is a human bone allograft produ... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Optimum Expanse R Grafton is a human bone allograft product containing dem... 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 Gel Multiple Sizes Grafton is a human bone allograft product ... 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 Flex Multiple Sizes Grafton is a human bone allograft product... Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... Class II Osteotech Inc
Apr 20, 2012 Optimum Expanse S 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
Apr 20, 2012 Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... 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 Crunch Multiple Sizes Grafton is a human bone allograft produ... 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 Matrix Strips Multiple Sizes Grafton is a human bone allograf... 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 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.