Facility

Molnlycke Manufacturing US, LLC

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

Key facts

3recalls · worst Class II

1inspections · worst NAI

—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)	3000719717
Establishment type	Manufacture Medical Device
Location	11 Twin Rivers Drive Wiscasset, ME, US 04578
Registration status	Active · expires 2026
Parent company	MOLNLYCKE HEALTH CARE US LLC (owner-operator 8030877)
Brand names	Tortoise Turning and Positioning System

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Device, Transfer, Patient, Manual
Product code FMR (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6785

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.

FDA inspections (1)

NAI2018-08-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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. “Molnlycke Manufacturing US, LLC (FEI 3000719717) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000719717-molnlycke-manufacturing-us-llc/

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