Browse Device Recalls

206 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 206 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 206 FDA device recalls in 2026.

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DateProductReasonClassFirm
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
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 WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM The mix up of the impression caps provided in the package. The provided impression caps are magen... Class III Straumann USA 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

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.