RegWardenFDA facility compliance records
Facility

MicroCare Medical

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

Activity by year

FDA actions on record by year2019: 1 inspections; 2024: 1 recalls201720181201920202021202220231202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Needle, Hypodermic, Single Lumen
    Product code FMI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5570

Recalls & enforcement

  • Class IIOngoing2024-08-29
    Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could resu…

FDA inspections (1)

  • NAI2019-08-29
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MicroCare Medical (FEI 1720499) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1720499-microcare-medical/

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