MOLNLYCKE HEALTH CARE (THAILAND), LTD.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Tape And Bandage, AdhesiveProduct code KGX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5240
Recalls & enforcement
- Class IITerminated2019-03-26Intermittent heat seal failures on the outer pouch of some EZ Derm products.
- Class IITerminated2017-07-26Products may not meet specifications due to possible presence of metal shavings.
- Class IIOngoing2017-04-24Sterilization validation failure.
Related
- All facilities operated by MOLNLYCKE HEALTH CARE US LLC
- Molnlycke Health Care SDN BHD (MY)
- Molnlycke Health Care AB (SE)
- Molnlycke Health Care Sdn. Bhd. (MY)
- Molnlycke Manufacturing US, LLC (ME)
- Molnlycke Health Care SDN BHD (MY)
- Molnlycke Health Care Oy (FI)
- MOLNLYCKE HEALTH CARE (GB)
- MOLNLYCKE MANUFACTURING US, LLC (ME)
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 (THAILAND), LTD. (FEI 3006607005) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006607005-molnlycke-health-care-thailand-ltd/
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