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.
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 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
- 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
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 →Related recalls
Same manufacturer · American Contract Systems Inc
See all →- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24