Facility

TRINITY STERILE, INC.

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

Key facts

3recalls · 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)	1000123297
Establishment type	Manufacture Medical Device
Location	201 Kiley Dr SALISBURY, MD, US 21801
Registration status	Active · expires 2026
Parent company	TRINITY STERILE, INC. (owner-operator 9003800)
Brand names	Joint Aspiration Tray

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (2)

Cannula, Ear
Product code JYC (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800
Aspiration Tray
Product code OJT (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IIOngoing2024-12-13
Potential for hole in package compromising sterility of the medical kit.
Class IITerminated2022-06-29
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Class IITerminated2021-02-23
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

FDA inspections (3)

NAI2024-05-23
No Action Indicated · Compliance: Devices
VAI2019-04-26
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2017-03-13
Voluntary Action Indicated · Compliance: 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 TRINITY STERILE, 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. “TRINITY STERILE, INC. (FEI 1000123297) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000123297-trinity-sterile-inc/

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