Browse Device Recalls

34,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,057 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 34,057 FDA device recalls — Class II.

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Date	Product	Reason	Class	Firm
Jan 7, 2026	Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Mod...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) L...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55;...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CD...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2)...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Spectral CT; Product Code (REF): 728333;	As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to...	Class II	Philips North America Llc
Jan 7, 2026	Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130;...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Brilliance iCT; Product Code (REF): 728306;	As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to...	Class II	Philips North America Llc
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYK...	Medline has identified issues related to calibration of the equipment used to sterilize and packa...	Class II	Medline Industries, LP
Jan 7, 2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 7, 2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V...	Devices which did not undergo thermoforming could deform and lose performance.	Class II	Olympus Corporation of the Americas
Jan 6, 2026	PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With ...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability W...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With ...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without ...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability W...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 6, 2026	PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or...	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co...	Class II	VANTIVE US HEALTHCARE LLC
Jan 5, 2026	Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa...	Class II	Medline Industries, LP
Jan 5, 2026	EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H...	942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever...	Class II	Encore Medical, LP
Jan 5, 2026	Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A...	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa...	Class II	Medline Industries, LP
Jan 5, 2026	Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal S...	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa...	Class II	Medline Industries, LP
Jan 5, 2026	EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705	942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever...	Class II	Encore Medical, LP
Jan 5, 2026	Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM ...	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa...	Class II	Medline Industries, LP
Jan 5, 2026	Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa...	Class II	Medline Industries, LP
Jan 5, 2026	Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI...	Due to a modification by a vendor and may be reinstalled without properly engaging the outside re...	Class II	Raz Design Inc
Jan 5, 2026	VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ...	Potential risk of Quality Control failures and/or false resistant antibiotic results when testing...	Class II	Biomerieux Inc
Jan 2, 2026	ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26...	Due a design issue where the navigated array connection geometry is incorrect.	Class II	Alphatec Spine, Inc.
Jan 2, 2026	ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26...	Due a design issue where the navigated array connection geometry is incorrect.	Class II	Alphatec Spine, Inc.
Jan 2, 2026	Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.	Tyvek bag seal issue which may compromise sterility of the kit.	Class II	AVID Medical, Inc.

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.