--- title: "Trinity Sterile, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Trinity Sterile, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/trinity-sterile-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Trinity Sterile, Inc. recall records **5** reported ongoing 9 records in this archive. Latest source date Dec 13, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 13, 2024 FDA device enforcement ### [Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing cha...](https://isitonrecall.com/recall/fda-device-z-1012-2025-brand-name-imed-products-product-name-dressing-change-kit-with-chloraprep-3ml-haloguard-model-catalo/) Potential for hole in package compromising sterility of the medical kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, PA, TN and TX. [Official source for Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1012-2025%22) Dec 13, 2024 FDA device enforcement ### [Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product...](https://isitonrecall.com/recall/fda-device-z-1013-2025-brand-name-wolf-pak-product-name-dressing-change-kit-with-transparent-dressing-3ml-chg-one-step-appl/) Potential for hole in package compromising sterility of the medical kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, PA, TN and TX. [Official source for Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One St...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1013-2025%22) Dec 13, 2024 FDA device enforcement ### [Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N...](https://isitonrecall.com/recall/fda-device-z-1014-2025-brand-name-wolf-pak-product-name-dressing-change-kit-with-cloth-border-tegaderm-dressing-3ml-chg-one/) Potential for hole in package compromising sterility of the medical kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, PA, TN and TX. [Official source for Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1014-2025%22) Dec 13, 2024 FDA device enforcement ### [Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing ...](https://isitonrecall.com/recall/fda-device-z-1015-2025-brand-name-wolf-pak-product-name-premium-dressing-change-kit-with-guardiva-statlock-cs-30-model-cata/) Potential for hole in package compromising sterility of the medical kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, PA, TN and TX. [Official source for Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Mod...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1015-2025%22) Dec 13, 2024 FDA device enforcement ### [Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 2...](https://isitonrecall.com/recall/fda-device-z-1016-2025-brand-name-tacy-medical-inc-product-name-dressing-change-tray-cs-20-model-catalog-number-tm6180cp-so/) Potential for hole in package compromising sterility of the medical kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, PA, TN and TX. [Official source for Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2025%22) Jun 29, 2022 FDA device enforcement ### [Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708](https://isitonrecall.com/recall/fda-device-z-1548-2022-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-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy Class II Reported terminated Distribution: US Nationwide distribution in the states of FL, PA. [Official source for Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1548-2022%22) Jun 29, 2022 FDA device enforcement ### [Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF](https://isitonrecall.com/recall/fda-device-z-1549-2022-wolf-pak-premium-dressing-kit-with-guardva-cs-30-ref-dc5030lf/) 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 II Reported terminated Distribution: US Nationwide distribution in the states of FL, PA. [Official source for Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1549-2022%22) Jun 29, 2022 FDA device enforcement ### [Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF](https://isitonrecall.com/recall/fda-device-z-1550-2022-wolf-pak-premium-dressing-change-kit-with-statlock-cs-30-ref-dc5040lf/) Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy Class II Reported terminated Distribution: US Nationwide distribution in the states of FL, PA. [Official source for Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1550-2022%22) Jun 29, 2022 FDA device enforcement ### [Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF](https://isitonrecall.com/recall/fda-device-z-1551-2022-wolf-pak-premium-dressing-change-kit-with-guardva-and-statlok-cs-30-ref-dc5090lf/) 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 II Reported terminated Distribution: US Nationwide distribution in the states of FL, PA. [Official source for Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1551-2022%22) ## Reasons in these listed records - Potential for hole in package compromising sterility of the medical kit. - 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 These examples come from this result page and are not a ranking of every recall reason. ## Checking Trinity Sterile, Inc. ### Is there a recall on trinity sterile, inc. right now? This archive contains 9 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Trinity Sterile, Inc.](https://isitonrecall.com/check/?q=Trinity%20Sterile%2C%20Inc.) 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