Facility

MOLNLYCKE HEALTH CARE

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

Key facts

3recalls · 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)	2819
Establishment type	Manufacture Medical Device
Location	TUBITON HOUSE OLDHAM, GB OL1 3HS
Registration status	Active · expires 2026
Parent company	MOLNLYCKE HEALTH CARE US LLC (owner-operator 8030877)
Brand names	Tubigrip; Setopress; Dermafit; Tubifast; Tubipad; Elset

Activity by year

Recalls (3)

Devices registered here (1)

Bandage, Elastic
Product code FQM (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5075

Recalls & enforcement

Class IITerminated2019-03-26
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
Class IITerminated2017-07-26
Products may not meet specifications due to possible presence of metal shavings.
Class IIOngoing2017-04-24
Sterilization validation failure.

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. “MOLNLYCKE HEALTH CARE (FEI 2819) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2819-molnlycke-health-care/

Not open yet

Alerts for MOLNLYCKE HEALTH CARE

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.