C-Section Surgical Packs Recalled Over Sterilization Assurance Failure
American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.
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: This is an FDA Class II recall of high-risk surgical equipment with a confirmed sterilization assurance failure. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
American Contract Systems Inc. is recalling C-Section Pack surgical kits (Model Nos LLCS44F and LLCS44F-01) due to inability to confirm that sterilization assurance requirements were met. Approximately 252 kits with lot numbers 70-051011, 70-051709, 70-052452, and 70-052952 are affected.
Because sterilization cannot be verified, the surgical packs risk loss of functionality, which could delay or prolong treatment during cesarean section procedures.
Customers should discontinue use and contact American Contract Systems Inc. for replacement or return instructions. Healthcare facilities should verify their inventory against the affected lot numbers and remove matching products from service.
The recalled product
- Product
- C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
- Manufacturer
- American Contract Systems Inc
- Affected units
- 252
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 (1)
- UDI-DI 00191072219107 Lots 70-051011 70-051709 70-052452 70-052952
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.
See all 32 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