Class IOngoingZ-3150-2026
Abiomed, Inc. recalls Impella Optical Controller
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Abiomed, Inc.MASep 23, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 674 recalls
Class IOngoingZ-3149-2026
Abiomed, Inc. recalls Impella Optical Controller with the below product descriptions and corresponding Produc…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Abiomed, Inc.MASep 23, 2026
Class IOngoingZ-3148-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and correspondin…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Abiomed, Inc.MASep 23, 2026
Class IIOngoingZ-3143-2026
GE Medical Systems Information Technologies Inc recalls Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
GE Medical Systems Inf…WISep 23, 2026
Class IIOngoingZ-3119-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bar…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3118-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Cath…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3117-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INT…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3116-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3115-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicon…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3114-2026
C.R. Bard Inc recalls Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF:…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
C.R. Bard IncGASep 16, 2026
Class IIOngoingZ-3089-2026
B Braun Medical Inc recalls Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Numb…
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
B Braun Medical IncPASep 9, 2026
Class IIOngoingZ-3088-2026
Medos International Sarl recalls Velys Enabling Tech Robotic-Assist Station REF: 451611001
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Medos International Sa…Sep 9, 2026