Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 13, 2025	Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.	Potential breach in pouch packaging which could lead to loss of sterility.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025	Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ...	Potential breach in pouch packaging which could lead to loss of sterility.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025	Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.	Potential breach in pouch packaging which could lead to loss of sterility.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025	Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC...	Potential breach in pouch packaging which could lead to loss of sterility.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025	Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P...	Potential breach in pouch packaging which could lead to loss of sterility.	Class II	MEDLINE INDUSTRIES, LP - Northfield
Feb 7, 2025	CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibril...	Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.	Class II	CardioFocus, Inc.
Feb 4, 2025	CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.	During an internal investigation, ACS was unable to confirm that the CODMAN component achieved th...	Class II	American Contract Systems Inc
Jan 31, 2025	Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat...	Sterility assurance with procedure trays	Class II	American Contract Systems, Inc.
Jan 31, 2025	Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Nu...	Sterility assurance with procedure trays	Class II	American Contract Systems, Inc.
Jan 31, 2025	Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack...	Sterility assurance with procedure trays	Class II	American Contract Systems, Inc.
Jan 3, 2025	Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien...	Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 20, 2024	PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Sutur...	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi...	Class II	Ethicon, LLC
Dec 20, 2024	ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so...	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi...	Class II	Ethicon, LLC
Dec 20, 2024	PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN...	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi...	Class II	Ethicon, LLC
Dec 19, 2024	Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE	Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.	Class II	Karl Storz Endoscopy
Dec 13, 2024	Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod...	Potential for hole in package compromising sterility of the medical kit.	Class II	Trinity Sterile, Inc.
Dec 13, 2024	Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres...	Potential for hole in package compromising sterility of the medical kit.	Class II	Trinity Sterile, Inc.
Dec 13, 2024	Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg...	Potential for hole in package compromising sterility of the medical kit.	Class II	Trinity Sterile, Inc.
Dec 13, 2024	Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ...	Potential for hole in package compromising sterility of the medical kit.	Class II	Trinity Sterile, Inc.
Dec 13, 2024	Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa...	Potential for hole in package compromising sterility of the medical kit.	Class II	Trinity Sterile, Inc.
Dec 2, 2024	Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA...	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.	Class II	Coloplast Manufacturing US, LLC
Dec 2, 2024	Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co...	Sterility assurance; microcatheter inner packaging may contain incomplete seal.	Class II	MICROVENTION INC.
Dec 2, 2024	X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB611...	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.	Class II	Coloplast Manufacturing US, LLC
Nov 19, 2024	SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (...	Incomplete or partial pouch seals, which may result in a breach in the sterility.	Class II	Med Michigan Holding Llc
Nov 12, 2024	ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	RUMMELL, Medline Item No. ST006ST	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024	ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Oct 21, 2024	Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ0404...	Tip protector may fall off within the packaging, resulting in compromised sterile barrier system ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024	Acrobat-i Positioner. Model Number C-XP-5000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Oct 16, 2024	Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Oct 16, 2024	Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z	Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste...	Class II	Maquet Cardiovascular, LLC
Oct 11, 2024	4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2...	Due to holes detected in the inner barrier system that may compromise the sterility of the affect...	Class II	Karl Storz Endoscopy
Oct 3, 2024	Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card...	There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can...	Class II	Medtronic Perfusion Systems
Sep 17, 2024	Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reus...	Due to pin coming off of handles.	Class II	MicroSurgical Technology Inc
Sep 13, 2024	MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A...	There is a potential for pinholes in the applicator pouch film which creates a sterility concern.	Class II	Integra LifeSciences Corp.
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
Aug 12, 2024	ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio...	Product packaging process may result in an improper or incomplete seal of the outer foil pouch su...	Class II	Smith & Nephew Inc.
Jul 18, 2024	Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001...	There is the potential for holes in the clear sterile barrier of the device pouch which may impac...	Class II	Boston Scientific Corporation
Jul 18, 2024	Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271...	There is the potential for holes in the clear sterile barrier of the device pouch which may impac...	Class II	Boston Scientific Corporation
Jul 18, 2024	vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Mate...	There is the potential for holes in the clear sterile barrier of the device pouch which may impac...	Class II	Boston Scientific Corporation
Jul 18, 2024	Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00...	There is the potential for holes in the clear sterile barrier of the device pouch which may impac...	Class II	Boston Scientific Corporation
Jul 18, 2024	VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M0012453...	There is the potential for holes in the clear sterile barrier of the device pouch which may impac...	Class II	Boston Scientific Corporation
Jul 1, 2024	Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi...	Due to packaging defects, sterility assurance and heparin activity may be compromised.	Class II	W L Gore & Associates, Inc.
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi...	Due to packaging defects, sterility assurance and heparin activity may be compromised.	Class II	W L Gore & Associates, Inc.
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas

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.