Agency classClass IIOur severity:High FDA (Devices)·Z-1702-2022·Announced 2022-09-14

Hysterectomy and Vaginal Packs Recalled for Improper Sterilization Validation

American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.

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 is a Class II medical device recall with no reported illnesses or injuries. The hazard is that improper sterilization validation could compromise device sterility and integrity, representing a risk-of-harm to surgical patients, though no actual harm has been documented.

Plain-English summary

American Contract Systems, Inc. is recalling 29 hysterectomy and vaginal packs because the products were exposed to multiple sterilization cycles without validation. The FDA classified this as a Class II recall.

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. Specific lot numbers and serial numbers have been identified by the FDA.

Improper sterilization validation could compromise the sterility and integrity of these medical devices, which are used in surgical procedures. Healthcare providers with these products should refer to the FDA recall notice for guidance on proper handling and next steps.

The recalled product

Product: Various hysterectomy, vaginal packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical / Hysterectomy Packs
Hazard: improper-sterilization
contamination-risk
Affected units: 29

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) LSRGYOSCOPYG
2104281
888211
63995389 2) LSRLMGLAPF
2105282
856211
44252282 3) LSRHPGYND
2106092
847211
14887375 4) LSRHPGYND
14887374 5) LSRHPGYND
14887373 6) AMJL22Z
2106112
840211
64176443 7) FDMN88N
2107013
821211

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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