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.
What this means for you
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.
- 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
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 →Related recalls
Same manufacturer · American Contract Systems, Inc.
See all →- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22