Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
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 Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2... 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) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U;... 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 OPHTHALMIC RUPTURE GLOBE, 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 Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003 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 Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJ... 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) TOTE ABRAMS KNEE ARTHROSCOPY, 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 Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR ... 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 Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 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: 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) NEURO SHUNT- CODMAN, Model Number: CDS860018G; ... 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) PLASTIC BIN W/MISC KITS, Model Number: ACC01049... 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 Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE14... 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) BURN PACK, Model Number: DYNJ15668R; 2) BURN ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 IQon Spectral CT; Product Code (REF): 728332; 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) ROBOTIC GYN CDS-1, Model Number: CDS982893I; ... 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) WMC I D PACK-LF, Model Number: DYNJ50806L 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) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; ... 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 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

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.