Merit Medical Systems, Inc. 2024-10-23 Health serious FDA
Health · FDA · Recall #FDA-Z-0062-2025
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe,… Recall
Issued October 23, 2024 · Merit Medical Systems, Inc.
In October 2024, Merit Medical Systems, Inc. recalled the Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
What you should do
- 1 Stop using Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Merit Medical Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Merit Medical Systems, Inc.
- Category
- Health
- Recall date
- October 23, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI,
- Recall number
- FDA-Z-0062-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Merit Medical Systems, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.