Agency classClass IIOur severity:High FDA (Devices)·Z-1701-2022·Announced 2022-09-14

Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves surgical packs with unvalidated sterilization, which poses a potential infection risk to patients. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, meeting the rubric criteria for High (Score 3) severity.

Plain-English summary

American Contract Systems is recalling certain obstetric and gynecology surgical packs (15 units total) distributed to health systems and medical device distributors in multiple U.S. states. These packs are used in surgical procedures and must maintain strict sterilization to ensure patient safety.

The recalled products were exposed to multiple sterilization cycles without validation or testing to confirm the packs remained safe and sterile after multiple exposures. This lack of validation could compromise the sterility integrity of the surgical instruments, potentially increasing infection risk for patients undergoing procedures.

The affected packs were distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Detailed identification information including tray numbers, sterilization lots, and batch serial numbers is available in the FDA's official recall notice. No illnesses or injuries related to these packs have been reported.

Health systems and distributors who have received these packs should consult the FDA recall notice and contact American Contract Systems for guidance on product disposition and replacement.

The recalled product

Product: Various ob/gyn packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Obstetric/Gynecology Surgical Supplies
Hazard: unvalidated-sterilization
infection-risk
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) LSROBDELIVC
2104091
904211
14531604 2) LSRVAGDELIVC
2106011
863211
44252284 3) LSRVAGDELIVC
44135283 4) LSRCFHVAGDC
2108042
791211
64123598 5) LSRCFHVAGDC
64123599 6) LSRCFHVAGDC
64123597 7) LSRVAGDELIVC
2108181
776211
44139780 8) LSROBDELIVC
2109231

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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Same hazard · unvalidated sterilization