MOLNLYCKE HEALTH CARE US LLC
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (9)
- Molnlycke Health Care SDN BHD FEI 3025355668 · MY
- Molnlycke Health Care AB FEI 3007048057 · SE
- Molnlycke Health Care Sdn. Bhd. FEI 3010309112 · MY
- Molnlycke Manufacturing US, LLC FEI 3000719717 · ME
- Molnlycke Health Care SDN BHD FEI 1000207790 · MY
- Molnlycke Health Care Oy FEI 3007605720 · FI
- MOLNLYCKE HEALTH CARE FEI 2819 · GB
- MOLNLYCKE HEALTH CARE (THAILAND), LTD. FEI 3006607005 · TH
- MOLNLYCKE MANUFACTURING US, LLC FEI 3010099071 · ME
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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “MOLNLYCKE HEALTH CARE US LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8030877-molnlycke-health-care-us-llc/
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