Trinity Sterile, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 1000123297

Trinity Sterile, Inc. is a medical device manufacturer, with 392 devices listed in FDA GUDID (FDA Class I, Class II and Unclassified) and 10 FDA recalls as of 12 Nov 2026.

Devices: 392
Registrations: FDA
FDA recalls: 105 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries: FDA GUDID 392
Device classes: FDA Class I 287
FDA Class II 92
FDA Unclassified 8
FDA recalls: 10 recalls matched by name
Identifiers: FDA FEI 1000123297

Catalogue392

Newest first, rows 1-50 of 392

Search and filter all 392 devices

Rows 1-50 of 392

Showing 1-50 of 392

Company details

FDA FEI number: 1000123297
Address: 201 Kiley Dr, SALISBURY, MD, 21801

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 1
2022 4
2023 0
2024 5
2025 0
2026 0

2024
- 13 Dec 2024 Z-1012-2025 Class II Ongoing Potential for hole in package compromising sterility of the medical kit. Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
- 13 Dec 2024 Z-1013-2025 Class II Ongoing Potential for hole in package compromising sterility of the medical kit. Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
- 13 Dec 2024 Z-1014-2025 Class II Ongoing Potential for hole in package compromising sterility of the medical kit. Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
- 13 Dec 2024 Z-1015-2025 Class II Ongoing Potential for hole in package compromising sterility of the medical kit. Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
- 13 Dec 2024 Z-1016-2025 Class II Ongoing Potential for hole in package compromising sterility of the medical kit. Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
2022
- 29 Jun 2022 Z-1548-2022 Class II Terminated 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 Distribution: US Nationwide distribution in the states of FL, PA.
- 29 Jun 2022 Z-1549-2022 Class II Terminated 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 Distribution: US Nationwide distribution in the states of FL, PA.
- 29 Jun 2022 Z-1550-2022 Class II Terminated 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 Distribution: US Nationwide distribution in the states of FL, PA.
- 29 Jun 2022 Z-1551-2022 Class II Terminated 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 Distribution: US Nationwide distribution in the states of FL, PA.
2021
- 23 Feb 2021 Z-1468-2021 Class II Terminated Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility Distribution: US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.

Frequently asked questions

How many devices does TRINITY STERILE, INC. have in the registry?

The registry currently lists 392 devices for TRINITY STERILE, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list TRINITY STERILE, INC.'s devices?

Among its 50 most recently registered devices, TRINITY STERILE, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do TRINITY STERILE, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for TRINITY STERILE, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for TRINITY STERILE, INC.?

FDA recall records list 10 recalls initiated by TRINITY STERILE, INC., the most recent initiated on 13 Dec 2024. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from TRINITY STERILE, INC. in the registry?

The most recently registered devices listed for TRINITY STERILE, INC. include Trinity Sterile, Inc. 5007M, Trinity Sterile, Inc. 50050, Trinity Sterile, Inc. 10001 and Trinity Sterile, Inc. 5086.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.