Laceration Trays Recalled Due to Sterility Assurance Concerns
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.
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 medical device for wound care where sterilization assurance cannot be confirmed. No illnesses or injuries reported. Per the rubric, high-risk medical devices without reported harm score 3 (High).
Plain-English summary
American Contract Systems Inc has recalled 690 laceration trays (Models SGLA07A, SGLA07B-01, SGLA07B-02, and SGLA07B) distributed nationwide. The manufacturer is unable to confirm that sterilization assurance requirements were met during manufacturing.
Sterilization is critical for medical devices used in wound care. Without confirmed sterilization, these trays may lose functionality or fail to operate properly. This could delay or prolong patient treatment.
Affected lot numbers are 899241, 70-050880, 70-051697, 70-052161, and 70-052662. Healthcare providers and facilities with these products should discontinue use immediately and contact American Contract Systems Inc for instructions on return or replacement.
This is an FDA Class II recall. For additional information, contact the FDA or visit the official recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1349-2025.
The recalled product
- Product
- LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 690
Distribution
Part of a larger recall action
This product is one of 32 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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