Facility

Epimed International, Inc.

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

Key facts

6recalls · 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)	1643059
Establishment type	Repack or Relabel Medical Device
Location	13958 Diplomat Drive Dallas, TX, US 75234
Registration status	Active · expires 2026
Parent company	Epimed International, Inc. (owner-operator 1316297)
Brand names	PainBlocker

Activity by year

Recalls (6)

Devices registered here (1)

Device, Surgical, Cryogenic
Product code GXH (opens in a new tab) · Class II · Neurology · 21 CFR 882.4250

Recalls & enforcement

Class IITerminated2021-02-01
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Class IITerminated2020-02-21
Incorrect expiration date on introduction cannula packaging.
Class IITerminated2019-06-18
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Class IICompleted2017-12-28
Potential for stylet to protrude from the distal end of the catheter
Class IITerminated2017-07-24
Potential for partially incomplete seal of product, impacting sterility.
Class IITerminated2016-04-22
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.

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. “Epimed International, Inc. (FEI 1643059) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1643059-epimed-international-inc/

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