Class IIOngoingZ-1137-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Recalls: Process change control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–72 of 185 recalls
Class IIOngoingZ-1042-2026
Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation d…
Boston Scientific Corp…MNJan 21, 2026
Class IIIOngoingZ-0932-2026
Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.NJDec 24, 2025
Class IIIOngoingZ-0931-2026
Datascope Corp. recalls Cardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.NJDec 24, 2025
Class IIOngoingZ-0567-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Collection Tube Extender
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0566-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0565-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0564-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0563-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0562-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0561-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025
Class IIOngoingZ-0560-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
ASP Global, LLC. dba A…GANov 26, 2025