Recall database

2026 device recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 553–564 of 1,678 recalls

Class IIOngoingZ-2134-2026

DJO, LLC recalls Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 S…

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

DJO, LLCCAMay 20, 2026

Class IIOngoingZ-2133-2026

On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

On-X Life Technologies…TXMay 20, 2026

Class IOngoingZ-2066-2026

Windstone Medical Packaging, Inc. recalls Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between…

Windstone Medical Pack…MTMay 20, 2026

Class IOngoingZ-2047-2026

Omnicell, Inc. recalls Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028

Potential for mislabeled syringe produced by the i.v.STATION device.

Omnicell, Inc.PAMay 20, 2026

Class IIOngoingZ-2132-2026

Orthorebirth Co Ltd recalls ZENBONE

Resorbable bone void filler falls outside standard specifications.

Orthorebirth Co LtdMay 13, 2026

Class IIOngoingZ-2131-2026

Orthorebirth Co Ltd recalls BioCera Fibers

Resorbable bone void filler falls outside standard specifications.

Orthorebirth Co LtdMay 13, 2026

Class IIOngoingZ-2130-2026

Medline Industries, LP recalls Medline Surgical Packs: 1) PACK

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles;…