Browse Device Recalls

3,263 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,263 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 3,263 FDA device recalls in IL.

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DateProductReasonClassFirm
Feb 18, 2026 Sterile Radiology Procedure Kits, Model Number DYNDH1491B There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which m... Class II Medline Industries, LP
Feb 18, 2026 Blue Ventilator Adapter Module, single-patient use circuit, Product Code M079... Urgent Medical Device Correction for the Volara system single-patient use circuit due to the pote... Class I Baxter Healthcare Corporation
Feb 18, 2026 Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... Class II Baxter Healthcare Corporation
Feb 16, 2026 MEDLINE ANTERIOR HIP PACK DYNJ64672B Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK,... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DY... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Airway Exam Kit, DYKE1796 Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 THORACIC ROBOTS, DYNJ908777B Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 13, 2026 ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC Connectors were not manufactured to required dimensional specifications and may not form a proper... Class II Medline Industries, LP
Feb 13, 2026 Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE C... Connectors were not manufactured to required dimensional specifications and may not form a proper... Class II Medline Industries, LP
Feb 10, 2026 Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAG... Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory respo... Class II Medline Industries, LP
Jan 30, 2026 Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) ... The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and acce... Class II Medline Industries, LP
Jan 28, 2026 Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,... Fabric may experience premature delamination when using included laundering instructions. Identif... Class II Medline Industries, LP
Jan 28, 2026 Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL ... Fabric may experience premature delamination when using included laundering instructions. Identif... Class II Medline Industries, LP
Jan 16, 2026 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Number... Under certain workflows, patient information shown in the viewer may not match the images display... Class II GE Healthcare
Jan 13, 2026 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3... Pumps were released without full testing being performed, including occlusion alarm testing. Class II Baxter Healthcare Corporation
Jan 8, 2026 Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS ... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHA... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Me... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG S... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2... 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 See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Num... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT ... 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 See complete list in RES, exceeds character limit. Medline Surgical Gowns 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) 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) 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 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) CVC PACK, Model Number: CVI4500A; 2) TOTE KAM... 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, Model Number: DYNJ35363A; 2) SICK... 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) 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) 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) CENTRAL LINE UNIVERSAL INSERTI, Model Number: C... 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 CATHETER INSERTION TRAY, Model Number: CVI... 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 UROLOGY SLING, Model Number: DYKMBNDL106; ... 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) C-SECTION PACK, Model Number: CDS820080N; 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) 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) 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) 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 See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GL... 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 Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP24... 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) ANGIO PROCEDURE PACK, Model Number:00-401824AA;... 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

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.