Trinity Sterile recalls

Trinity Sterile has 10 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 29 Jan 2025. 5 are still ongoing. The most frequent reason is sterility.

Total recalls10since 2021

Last 12 months0reported

Class I00% of total

Ongoing5latest 29 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 5Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 100%Class III 0 0%

Why trinity sterile is recalled

Sterility660%
Labeling Errors440%

Product types

By year

2025550%
2022440%
2021110%

Ongoing trinity sterile recalls

5 active

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled	Trinity Sterile	Sterility	Nationwide

All trinity sterile recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Dressing Change Kit recalled by Trinity Sterile	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled	Trinity Sterile	Sterility	Nationwide
29 Jan 2025Device	CLASS II	Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled	Trinity Sterile	Sterility	Nationwide
24 Aug 2022Device	CLASS II	Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 recalled	Trinity Sterile	Labeling Errors	Nationwide
24 Aug 2022Device	CLASS II	Wolf Pak Premium Dressing Change Kit with Statlock CS/30 recalled	Trinity Sterile	Labeling Errors	Nationwide
24 Aug 2022Device	CLASS II	Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 recalled	Trinity Sterile	Labeling Errors	Nationwide
24 Aug 2022Device	CLASS II	Sklar Instruments IV Cath Dressing Tray Cs/25 Re recalled	Trinity Sterile	Labeling Errors	Nationwide
28 Apr 2021Device	CLASS II	Midline Catheter Dressing Change Kit with Statlock recalled	Trinity Sterile	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.