RegWardenFDA facility compliance records
Company

CAREstream Medical LTD

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

Recalls by year

FDA actions on record by year2018: 1 recalls20171201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-05-15
    Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.

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. “CAREstream Medical LTD — 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-10044901-carestream-medical-ltd/

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