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