Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
May 30, 2013 ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irr... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
May 30, 2013 ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for j... Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... Class II Linvatec Corp. dba ConMed Linvatec
Mar 18, 2013 Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores a... The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code ... Class II Linvatec Corp. dba ConMed Linvatec
Mar 6, 2013 GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade ... Incorrect blue/white suture was used. Class II Linvatec Corp. dba ConMed Linvatec
Jan 24, 2013 D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Jan 24, 2013 D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Nov 15, 2012 ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthope... ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diamet... Class II Linvatec Corp. dba ConMed Linvatec
Jul 6, 2012 PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConM... ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diamete... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CON... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CO... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CON... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 US... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***... Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items ... Class II Linvatec Corp. dba ConMed Linvatec
Apr 10, 2012 "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATE... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... Class II Linvatec Corp. dba ConMed Linvatec
Apr 10, 2012 "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVA... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... Class II Linvatec Corp. dba ConMed Linvatec
Apr 9, 2012 "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 1... ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect ... Class II Linvatec Corp. dba ConMed Linvatec
Aug 12, 2011 CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The i... ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibilit... Class II Linvatec Corp. dba ConMed Linvatec
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
May 20, 2011 ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec
May 20, 2011 ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec

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.