Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 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 709 FDA device recalls in CT.

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DateProductReasonClassFirm
May 22, 2018 Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 1, 2018 Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be util... Device was marketed for uses outside the 510(k) clearance. Class II Hobbs Medical, Inc.
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

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.