Browse Device Recalls

334 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 334 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 334 FDA device recalls.

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DateProductReasonClassFirm
Apr 29, 2019 MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009... The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for ... Class II COVIDIEN LLC
Mar 13, 2019 Procedure kits include devices from the affected lots distributed OUS only: ... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Feb 15, 2019 Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 The product does not meet sterility requirements. Product labeled as sterile was distributed wit... Class II COVIDIEN LLC
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
Apr 9, 2018 EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, P... There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... Class II Covidien LLC
Apr 9, 2018 EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, P... There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... Class II Covidien LLC
Mar 15, 2018 LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipola... Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged de... Class II Covidien LLC
Dec 13, 2017 Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia... Product reportedly shutting down during use. Class II Covidien LLC
Nov 21, 2017 Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato... Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne... Class II Covidien LLC
Oct 12, 2017 Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Si... This voluntary recall is being conducted due to the potential for failure to detect the affected... Class II Covidien LLC
Sep 21, 2017 GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastr... Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastri... Class II Covidien LLC
Sep 15, 2017 Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial r... The device cartridge disengaged during use due to manufacturing error. Class II Covidien LLC
Sep 13, 2017 Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal... Potential for failure of the device safety interlock. The safety interlock prevents an empty sing... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
May 9, 2017 Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The ... Cotton tip of the device may disengage due to insufficient adhesive Class II Covidien LLC
Mar 3, 2017 Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm),... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curi... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile It... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC

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.