Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Jan 7, 2026 Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: P... 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) ARTHROSCOPY CDS, Model Number: CDS984609B; 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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KI... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
Dec 31, 2025 Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET... Under circumstances involving exposure to particular chemicals and mechanical forces, the male lu... Class II Medline Industries, LP
Dec 26, 2025 Chest Drainage Units and Accessories: Product Code Description 1. 88885... The firm is updating the IFU to clarify the intended patient population for the identified chest ... Class II Cardinal Health 200, LLC
Dec 24, 2025 Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit S... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Ki... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... 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.