Class IIOngoingZ-1928-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,165–1,176 of 2,088 recalls
Class IIOngoingZ-1927-2026
Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Under Investigation by firm
Foundation Medicine, I…MAApr 29, 2026
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
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