Facility

Amerx Healthcare Corp

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

Key facts

4recalls · worst Class II

1inspections · 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)	3012535730
Establishment type	Repack or Relabel Medical Device
Location	164 Douglas Road East Oldsmar, FL, US 34677
Registration status	Active · expires 2026
Parent company	Amerx Health Care Corporation (owner-operator 10029882)
Brand names	Foam with adhesive 4 x 4; Foam with adhesive 2 x 2; Foam 2 x 2; Calcium Alginate Pad 4 x 4; Foam 4 x 4

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Dressing, Wound, Hydrophilic
Product code NAC (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4018

Recalls & enforcement

Class IITerminated2016-05-20
Product did not meet specifications for Zinc Acetate (OOS).
Class IITerminated2015-02-25
Nonapproved labeling claims (Sterile)
Class IITerminated2014-09-26
Formulation deviation
Class IITerminated2014-07-11
Not approved labeling claims (antimicrobial and autolytic debridement)

FDA inspections (1)

VAI2020-03-03
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 Amerx Health Care Corporation

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. “Amerx Healthcare Corp (FEI 3012535730) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012535730-amerx-healthcare-corp/

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