Browse Device Recalls

1,730 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,730 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 1,730 FDA device recalls.

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DateProductReasonClassFirm
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Prod... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 3, 2018 Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... The packaging sterile barrier does not comply with the applicable packaging standard for terminal... Class II Medtronic Neurosurgery
May 2, 2018 Heartware Medtronic HVAD System for cardiac use. Including the following pa... Possible transient electrical connection interruption between an HVAD System power source (Batter... Class I Heartware
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BY... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo G... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA un... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BY... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BO... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKT... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) P... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA univer... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLE... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA uni... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BO... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The End... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and En... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal an... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and E... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA uni... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HE... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA univer... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 24, 2018 Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... Class II Medtronic Inc.
Mar 23, 2018 Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... Slot screw had an overall length of 15mm, but per the specification, the screw should have an ove... Class II Medtronic Sofamor Danek USA Inc
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... Class II Medtronic Navigation, Inc.
Mar 13, 2018 Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical ... Class II Medtronic Sofamor Danek USA 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.