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Trinity Sterile, Inc.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Trinity Sterile, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Trinity Sterile, Inc.

Date Product Reason Class
Dec 13, 2024 Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... Potential for hole in package compromising sterility of the medical kit. Class II
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... Potential for hole in package compromising sterility of the medical kit. Class II
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... Potential for hole in package compromising sterility of the medical kit. Class II
Dec 13, 2024 Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... Potential for hole in package compromising sterility of the medical kit. Class II
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... Potential for hole in package compromising sterility of the medical kit. Class II
Jun 29, 2022 Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adhere... Class II
Jun 29, 2022 Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adhere... Class II
Jun 29, 2022 Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5... Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adhere... Class II
Jun 29, 2022 Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adhere... Class II
Feb 23, 2021 Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... Evidence of face masks or other material in the seal in several kits, causing... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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