American Contract Systems recalls medical procedure kits with model GRRB10E and SPVH62P due to unverified sterilization. Affected kits may not meet safety standards.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling medical procedure kits labeled ROBOT HYST PACK (GRRB10E) and VAG HYST PACK (SPV: SPVH62P) because some components cannot be properly sterilized. This means the kits may not meet safety standards for medical use.
The recall states that certain components in these kits were not properly sterilized as per the manufacturer's procedures. This could mean the kits do not meet safety standards for medical use, potentially leading to infections or other complications.
Healthcare providers using these medical procedure kits are most at risk. Patients receiving procedures with these kits could be affected if the sterilization process was not properly followed.
Check for kits labeled 'ROBOT HYST PACK' with model number GRRB10E or 'VAG HYST PACK' with model number SPVH62P. Lot numbers for GRRB10E are 42-8157011 and 42-8126811; for SPVH62P, lot numbers are 12-7322911 and 12-7384911.
Look for the model numbers GRRB10E or SPVH62P on the kit labels.
The manufacturer determined that some components in these kits cannot be properly sterilized according to their procedures, so the kits may not meet safety standards.
The recall record does not specify a remedy, so contact American Contract Systems for guidance.
Yes, for GRRB10E: lot numbers 42-8157011 and 42-8126811; for SPVH62P: lot numbers 12-7322911 and 12-7384911.
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-2471-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2471-2025 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.
