Medical procedure kits recalled for unconfirmed sterilization assurance
American Contract Systems is recalling surgical procedure kits (cranial and shunt packs) because the manufacturer cannot confirm that sterilization assurance requirements were met for certain components.
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: This is a risk-of-harm product (surgical procedure kits) where no illnesses or injuries have been reported. The hazard—unconfirmed sterilization assurance—is theoretical, placing it at the maximum score of 3 per the rubric for Class II recalls without reported adverse effects.
Plain-English summary
American Contract Systems Inc is recalling 204 surgical procedure kits distributed in Illinois and Louisiana. The recall involves two products: SFCH CRANI PACK (model UICR10W) and SFCH SHUNT PACK (model UISH55V).
During an internal investigation, the manufacturer determined that the sterilization rationale for certain components was not justified. As a result, some components are not suitable for sterilization according to the company's procedures, and the manufacturer is unable to confirm that sterilization assurance requirements were met.
Unconfirmed sterilization of surgical kits poses a potential risk of surgical site infection. Patients who received procedures using these kits should consult their healthcare provider if they experience signs of infection, including fever, redness, swelling, or drainage at the surgical site.
Healthcare facilities that received these kits should cease use and contact American Contract Systems Inc for instructions on 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 — Surgical Kits
- Hazard
- improper-sterilization
- infection-risk
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:
- IL
- LA
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