Browse Device Recalls

1,303 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,303 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 1,303 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 25, 2026 Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TR... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440 The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJS... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number:... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PAC... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO P... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model N... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DY... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
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 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 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

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.