Class IIOngoingZ-1926-2026
SurgiSmoke Solutions recalls Flamingo Funnel Large
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke SolutionsMNApr 29, 2026
All device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 757–768 of 4,586 recalls
Class IIOngoingZ-1925-2026
SurgiSmoke Solutions recalls Flamingo Funnel Medium
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke SolutionsMNApr 29, 2026
Class IIOngoingZ-1924-2026
SurgiSmoke Solutions recalls Flamingo Funnel Small
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke SolutionsMNApr 29, 2026
Class IIOngoingZ-1923-2026
Remel Europe Ltd. recalls Oxoid Agglutinating Sera
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Remel Europe Ltd.Apr 29, 2026
Class IIOngoingZ-1922-2026
Beckman Coulter, Inc. recalls Access Total T4 Calibrator
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications.…
Beckman Coulter, Inc.MNApr 29, 2026
Class IIOngoingZ-1921-2026
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
Windstone Medical Pack…MTApr 29, 2026
Class IIOngoingZ-1920-2026
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
Windstone Medical Pack…MTApr 29, 2026
Class IIOngoingZ-1919-2026
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Lar…
Windstone Medical Pack…MTApr 29, 2026
Class IIOngoingZ-1918-2026
Micro-X Ltd. recalls Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Micro-X Ltd.Apr 29, 2026
Class IIOngoingZ-1917-2026
ARROW INTERNATIONAL, LLC recalls Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Cath…
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
ARROW INTERNATIONAL, L…NCApr 29, 2026
Class IIOngoingZ-1916-2026
ARROW INTERNATIONAL, LLC recalls MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-111…
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
ARROW INTERNATIONAL, L…NCApr 29, 2026
Class IIOngoingZ-1915-2026
ARROW INTERNATIONAL, LLC recalls Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI c…
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
ARROW INTERNATIONAL, L…NCApr 29, 2026