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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.