Facility

FLEXICARE MEDICAL (DONGGUAN) LTD.

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

Key facts

3recalls · worst Class I

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006061749
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	No. B-15 XICHENG INDUSTRIAL ZONE DONGGUAN CITY Guangdong, CN 52346
Registration status	Active · expires 2026
Parent company	FLEXICARE MEDICAL LTD. (owner-operator 8021995)
Brand names	FLEXICARE SILICONE ANAESTHETIC FACE MASKS; FLEXICARE ANAESTHETIC MASKS; InspiraMask; SootherMask

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Mask, Gas, Anesthetic
Product code BSJ (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5550

Recalls & enforcement

Class IOngoing2025-07-11
Laryngoscope handles may not illuminate as intended.
Class ITerminated2020-09-22
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
Class IITerminated2019-11-27
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity whic…

FDA inspections (1)

VAI2024-03-21
Voluntary Action Indicated · Compliance: 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.

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. “FLEXICARE MEDICAL (DONGGUAN) LTD. (FEI 3006061749) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006061749-flexicare-medical-dongguan-ltd/

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