Facility

EXSURCO MEDICAL, INC.

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)	3011981870
Establishment type	Manufacture Medical Device
Location	10804 GREEN RD Wakeman, OH, US 44889
Registration status	Active · expires 2026
Parent company	Exsurco Medical, Inc. (owner-operator 10053475)
Brand names	Amalgatome® SD

Activity by year

Recalls (1)

Devices registered here (1)

Dermatome
Product code GFD (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4820

Recalls & enforcement

Class IITerminated2018-04-17
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.

All facilities operated by Exsurco Medical, Inc.

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. “EXSURCO MEDICAL, INC. (FEI 3011981870) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011981870-exsurco-medical-inc/

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