American Contract Systems recalls sterile surgical gowns made in an unregistered FDA facility. Affected lots include specific tray numbers and expiration dates. Consumers should contact the manufacturer for details.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile surgical gowns that were manufactured in a facility not registered with the FDA. This could pose a risk of using unapproved medical products during surgery.
The gowns were made in a facility that hasn't been registered with the FDA. This means the products might not meet medical safety standards, potentially leading to complications during surgery.
Surgical teams and hospitals that use these sterile custom packs for procedures. Patients and staff are at risk if the gowns are used in surgery without proper FDA registration.
Check for specific tray numbers and expiration dates listed in the recall: AGTA481 (Lot # 998201, Exp. 01/02/2021), WXEN11G (Lot # 994201, Exp. 01/06/2021), and other lots with their respective expiration dates.
Look for the tray number and expiration date on the packaging to see if it matches the recalled lots listed in the notice.
The surgical gowns were manufactured in a facility not registered by the FDA, which could mean they don't meet medical safety standards.
Contact American Contract Systems directly for details on how to handle the recalled items.
Yes, specific tray numbers and expiration dates are listed in the recall notice, such as AGTA481 (Lot # 998201, Exp. 01/02/2021).
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2173-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2173-2020 from American Contract Systems. 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.