CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Medical Procedure kits and trays labeled as recalled
American Contract Systems is recalling Medical Procedure kits and trays labeled as: Sfch Crani Pack (PS 132432), distributed in Illinois, Louisiana. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2468-2025
- FDA event ID
- 97358
- Recalling firm
- American Contract Systems, Tiffin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2025
- FDA classified
- 28 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Jul 2025 | Recall initiated by company | |
| 28 Aug 2025 | Classified by FDA | +45 days |
| 3 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US distribution to states of: IL and LA
Questions about this recall
Why was it recalled?
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Which lots are affected?
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.
Where was it sold?
US distribution to states of: IL and LA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 97358This product is part of a recall event; the main page for the event is Medical Procedure kits and trays labeled as: Anterior Hip Pack recalled.
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