Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process
American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.
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 instruments with potentially compromised sterility due to inadequate sterilization. While no illnesses or injuries have been reported, sterilization failure in surgical instruments poses a direct risk of infection to patients undergoing medical procedures, meeting the criteria for a High severity rating.
Plain-English summary
American Contract Systems, Inc. is recalling 29 Gyn Laparoscopy convenience kits due to an issue with the sterilization process. The kits were sterilized with insufficient aeration time, which may have compromised their sterility. This affects surgical instruments' ability to prevent infection during gynecological laparoscopic procedures.
The recall applies to two models distributed nationwide: Model SLGL64K (Lot 981241, Exp. 1/19/2025) and Model SMGY46A (Lot 982241, Exp. 1/18/2025). These kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
The recalled product
- Product
- American Contract Systems Gyn Laparoscopy convenience kit
- Manufacturer
- American Contract Systems, Inc.
- 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 (6)
- (1) Model No SLGL64K - UDI-DI 00191072202017
- Lot 981241
- Exp. Date 1/19/2025
- and (2) Model No SMGY46A - UDI-DI 00191072188458
- Lot 982241
- Exp. Date 1/18/2025.
Distribution
Part of a larger recall action
This product is one of 8 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.
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