American Contract Systems recalls sterile surgical gowns manufactured in an unregistered FDA facility. Affected kits 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 used in procedures because they were made in a facility not registered with the FDA. This could lead to unsafe medical use if the gowns are used without proper regulatory oversight.
The gowns were manufactured in a facility that isn't registered with the FDA, which means they might not meet safety standards for medical use. This could lead to infections or other complications during surgery if the gowns are used without proper oversight.
Surgical teams and hospitals that use these sterile surgical gowns are affected. Patients and medical staff at risk if the recalled gowns are used in procedures.
Check for tray numbers like AGMV151, AGLA66H, or AGVA31H on the packaging. Look for specific lot numbers and expiration dates listed in the recall notice.
Reach out to American Contract Systems directly for details about the affected kits and next steps.
The recall states the gowns were manufactured in an unregistered FDA facility, so they may not meet safety standards. Do not use them until the manufacturer confirms they are safe.
The recall includes 12 kits from Lot #993201, 18 kits from Lot #676191, and other specific quantities across different tray numbers.
Contact American Contract Systems to determine if your specific kit is affected and follow their instructions.
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-2175-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2175-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
