Browse Device Recalls
1,300 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,300 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 1,300 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) PICC LINE TRAY, Model Number:00-401993O; 2) 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) 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 | See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS,... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model ... | 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) ANGIO PROCEDURE PACK, Model Number:00-401824AB;... | 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.