Facility

PEMCO, INC.

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

Key facts

1recalls · worst Class II

3inspections · worst VAI

—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)	1519227
Establishment type	Manufacture Medical Device
Location	5663 BRECKSVILLE RD. Cleveland, OH, US 44131
Registration status	Active · expires 2026
Parent company	PEMCO, INC. (owner-operator 1519227)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Stabilizer, Heart
Product code MWS (opens in a new tab) · Class I · Cardiovascular · 21 CFR 870.4500

Recalls & enforcement

Class IITerminated2013-07-10
The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.

FDA inspections (3)

VAI2024-10-25
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-12-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-10-25
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

All facilities operated by PEMCO, 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. “PEMCO, INC. (FEI 1519227) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1519227-pemco-inc/

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