Agency classClass IIOur severity:High FDA (Devices)·Z-1694-2022·Announced 2022-09-14

Laparoscopy surgical instrument packs recalled for sterilization validation failure

American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.

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: FDA Class II recall involving surgical instruments with a documented sterilization validation failure. This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria. The concern is theoretical but material: unvalidated sterilization could compromise instrument sterility.

Plain-English summary

American Contract Systems, Inc. is recalling 39 laparoscopy packs—surgical instrument trays used in laparoscopic procedures. The recalled products were exposed to multiple sterilization cycles without validation that the sterilization method was safe for repeated exposures.

The affected packs were distributed to health systems and medical distributors across 13 U.S. states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Specific lot and serial numbers are documented for each affected unit.

Without proper validation of the sterilization process for multiple cycles, the sterility and safety of the surgical instruments may be compromised. No illnesses or injuries related to these products have been reported to date.

Customers who received these items should contact American Contract Systems, Inc. for instructions on handling the recalled products.

The recalled product

Product: Various Laparoscopy Packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Instruments
Hazard: sterilization-failure
contamination-risk
Affected units: 39

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) LSRENDOSCOPH
2104281
890211
14887854 2) LSRENDOSCOPH
2108251
784211
44375070 3) LSRENDOSCOPH
2110011
740211
15140201 4) PLLA88I
2104162
895211
14779054 5) AMGL09X
887211
64029666 6) IHGB89AB
2107293
791211

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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