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.
- Hazard
- sterilization-failure
- contamination-risk
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:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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