The Recall Desk
Severity pendingFDA (Devices)·Z-2465-2025·Announced 2025-09-03

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/

Pending LLM rewrite. Source: FDA_DEVICE Z-2465-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

The recalled product

Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
Manufacturer
American Contract Systems Inc
Category
Medical Device — Devices

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)

  • 1) Model/Item Number CILC69L: UDI/DI 00191072235503
  • Kit Lot Numbers: 42-7937111
  • 42-8049311
  • 2) Model/Item Number HNLC80J: UDI/DI 00191072193650
  • Kit Lot Numbers: 42-8044511
  • 42-8118911
  • 42-7977011
  • 42-7803211
  • 3) Model/Item Number JKLC55H: UDI/DI 00191072235138
  • Kit Lot Numbers: 42-7814311
  • 4) Model/Item Number LLLA21K: UDI/DI 00191072233486
  • Kit Lot Numbers: 70-052582
  • 70-053048
  • 70-051564
  • 70-051373
  • 70-051163
  • 70-053446
  • 70-053776
  • 5) Model/Item Number MPGL15G: UDI/DI 00191072223197
  • Kit Lot Numbers: 5436916

Distribution

Distributed in 2 states:

  • IL
  • LA

Related recalls

Same category