Browse Device Recalls

690 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 690 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 690 FDA device recalls.

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DateProductReasonClassFirm
Nov 15, 2018 Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Nov 15, 2018 Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Mate... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Nov 15, 2018 Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, ... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Nov 5, 2018 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), ... The product was released into commercial distribution while subject to importation refusal. Class II COVIDIEN LLC
Oct 31, 2018 Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... Class II COVIDIEN LLC
Oct 5, 2018 Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Prod... The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failur... Class II Covidien LLC
Sep 18, 2018 Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... Class I COVIDIEN LLC
Aug 17, 2018 EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28... The firm identified the potential for a device to have an incorrect tissue gap. Use of a device w... Class II COVIDIEN LLC
Aug 1, 2018 Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Aug 1, 2018 Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ... Potential for product sterility breach due to a compromised or pinched seal defect Class II COVIDIEN LLC
Jul 26, 2018 Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Prod... Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Moni... Class II Covidien LLC
Jul 11, 2018 TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywi... The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jul 11, 2018 P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS The temperature sensor catheters may be defective in that they will show a lower body temperature... Class II COVIDIEN LLC
Jun 15, 2018 Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number ... Potential proplylene glycol contamination Class II Covidien LLC
May 22, 2018 Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 6... 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 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
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

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.