High FDA (Devices)·Z-2466-2025·Announced 2025-09-03

Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements

American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 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 Cysto, model/item number ASCY24A; Cysto Pack, model/item numbers BUCY78E and LMCP22T; and TUR Basin Pack, model/item number LMTU31T, are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072201621 for the Cysto kit. The recall covers 1,127 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) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
Manufacturer: American Contract Systems Inc
Category: Medical Device — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 1,127

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 ASCY24A: UDI/DI 00191072201621
Kit Lot Numbers: 12-7370111
12-7388611
12-7139611
12-7191911
12-7231611
12-7263911
2) Model/Item Number BUCY78E: UDI/DI 00191072235350
Kit Lot Numbers: 42-7962811
3) Model/Item Number LMCP22T: UDI/DI 00191072235510
Kit Lot Numbers: 42-8027411
42-8106111
42-7885511
42-7823511
4) Model/Item Number LMTU31T: UDI/DI 00191072235527
Kit Lot Numbers: 42-7987311
42-8059311
42-8112211
42-7832311
42-7845011

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