Facility

AB ULAX

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3004030908
Establishment type	Manufacture Medical Device
Location	MERKURIUSGATAN 8 MOTALA Ostergotland, SE 59132
Registration status	Active · expires 2026
Parent company	AB ULAX (owner-operator 9070340)
Brand names	6010 HME Trach Oxygen 6mm; MP25841 CH Care HME Trach; 1002 HME Medium; 6000 HME Trach; TFH104; 1001 HME Small; 1003 HME Large; 3300 HME Flex; Foam Filter; MP05845 HME HumidStar 2 Plus; MP05750 HME HumidStar Trach Plus; 2200 Flexsoft

Activity by year

Recalls (1)

Devices registered here (1)

Condenser, Heat And Moisture (Artificial Nose)
Product code BYD (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5375

Recalls & enforcement

Class IITerminated2020-09-04
Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to …

All facilities operated by AB ULAX

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. “AB ULAX (FEI 3004030908) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004030908-ab-ulax/

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