Agency classClass IIOur severity:High FDA (Devices)·Z-2468-2025·Announced 2025-09-03

Craniotomy and shunt packs recalled over unjustified sterilization of certain components

American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 neurosurgical procedure pack is a potential harm and no injuries are reported.

Plain-English summary

American Contract Systems medical procedure kits and trays labelled as SFCH Crani Pack (PS 132432), model/item number UICR10W, and SFCH Shunt Pack (PS 139798), model/item number UISH55V, are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072207241 for the crani pack. The recall covers 204 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) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Manufacturer: American Contract Systems Inc
Category: Medical Device — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 204

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 (10)

1) MODEL/ITEM NUMBER UICR10W: UDI/DI 00191072207241
Kit Lot Numbers: 42-7828711
42-7980711
42-8063211
42-8124011
2) MODEL/ITEM NUMBER UISH55V: UDI/DI 00191072235442
Kit Lot Numbers: 42-7799111
42-7985211
42-8065111
42-8140711.

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