Merit Medical recalls Melrose Wakefield Hospital 30 ATM angiographic injectors due to Tyvek barrier holes that could allow contamination. Affected units have specific lot numbers and were sold between 2021-2023.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Merit Medical is recalling its Melrose Wakefield Hospital 30 ATM angiographic injectors because manufacturing defects created holes in the Tyvek sterile barrier. This could allow contaminants to enter the device during medical procedures, potentially causing infections.
The Tyvek sterile barrier has manufacturing defects that create holes. These holes could allow contaminants to enter the device during medical procedures, potentially causing infections. The risk is low because the device is used in controlled medical settings with proper sterilization protocols.
Healthcare professionals using the Melrose Wakefield Hospital 30 ATM injectors for angioplasty procedures are most at risk. Patients receiving these devices during procedures may also be affected if the barrier is compromised.
Check for the product name 'Melrose Wakefield Hospital REF K05T-2159' on the device. Look for lot numbers: T2417859 through T2893877. These units were sold between 2021 and 2023.
Look for lot numbers T2417859 through T2893877 on the device packaging or label.
Due to manufacturing defects that create holes in the Tyvek sterile barrier, which could allow contaminants to enter the device during medical procedures.
Check for the product name 'Melrose Wakefield Hospital REF K05T-2159' and lot numbers T2417859 through T2893877.
The recall record does not specify any remedy or corrective action.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0062-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0062-2025 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
