High FDA (Devices)·Z-2465-2025·Announced 2025-09-03

Lap chole and laparoscopy packs recalled over unmet sterilization assurance requirements

American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; unconfirmed sterility on a surgical procedure pack is a potential harm and no injuries are reported.

Plain-English summary

American Contract Systems medical procedure kits and trays labelled as Lap Chole Pack under model/item numbers CILC69L, HNLC80J and JKLC55H, and a Laparoscopy Pack listed in the recall notice, are being recalled. Affected kit lot numbers are listed per item, with UDI/DI 00191072235503 for model CILC69L. The recall covers 1,233 units distributed in Illinois and Louisiana.

During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified and that some components are not fit for further sterilization according to its procedures. As a result, the firm is unable to confirm that product sterilization assurance requirements were met. The FDA classified the action as Class II.

Hospitals and surgical centres holding these lot numbers should quarantine affected stock and follow the manufacturer's instructions for return or replacement.

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 — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 1,233

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:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · American Contract Systems Inc

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Same hazard · sterility assurance