Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 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 675 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - P...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
May 17, 2019	EGIA45 CT AR MD THK REL, EGIA45CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
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	Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosu...	Potential for the sterile packaging to be compromised	Class II	Covidien, PLC
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

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.