RegWardenFDA facility compliance records
Company

Bayer Medical Care Inc.

8 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2018: 3 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2026: 2 recalls201732018201912020120211202220232024202522026
  • Recalls (8)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2026-07-31
    Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
  • Class IIOngoing2026-04-24
    Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved th…
  • Class IIOngoing2022-11-30
    Black specks may be present on the packaged needles
  • Class IITerminated2021-09-14
    Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
  • Class IITerminated2020-10-05
    Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
  • Class IITerminated2018-12-14
    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
  • Class IITerminated2018-09-07
    Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
  • Class IITerminated2018-06-28
    The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disenga…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Bayer Medical Care Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2520313-bayer-medical-care-inc/

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