The Recall Desk
HighFDA (Devices)·Z-1336-2025·Announced 2025-03-26

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
Category
Medical Device — Surgical Equipment
Hazard
  • sterilization-failure
  • loss-of-functionality

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

Distributed nationwide across the United States.

Related recalls

Same category