RegWardenFDA facility compliance records
Facility

SUNMED AP, LTD.

3 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2016: 1 recalls, 1 inspections; 2026: 1 inspections1’12’131’14’152’16’17’18’19’20’21’22’23’24’251’26
  • Recalls (3)
  • Inspections (2)

Devices registered here (1)

  • Ventilator, Emergency, Powered (Resuscitator)
    Product code BTL (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5925

Recalls & enforcement

  • Class IITerminated2016-03-15
    Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an …
  • Class ITerminated2014-05-16
    The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
  • Class ITerminated2012-07-11
    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

FDA inspections (2)

  • NAI2026-03-05
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2016-03-31
    No Action Indicated · Compliance: Devices

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. “SUNMED AP, LTD. (FEI 3005998497) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005998497-sunmed-ap-ltd/

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