Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
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: This is an FDA Class II recall involving a potential sterility assurance failure on surgical equipment. No illnesses, injuries, or deaths have been reported. The classification reflects risk-of-harm from inadequate sterilization of surgical instruments without documented patient impact.
Plain-English summary
American Contract Systems Inc is recalling the CRANI PACK, Model WECR41D, a medical procedure kit used in cranial surgery. The recall affects 91 units that were distributed to facilities in Michigan.
During an internal investigation, the manufacturer was unable to confirm that a component within the kit achieved the required Sterility Assurance Level. Because of this uncertainty, the kit cannot be reliably sterilized according to the manufacturer's procedures and is unsuitable for use in surgical applications.
Healthcare facilities that received affected units should immediately discontinue use and contact American Contract Systems Inc for return and replacement instructions. The affected lot codes have expiration dates ranging from July 2025 to December 2025. Patients who may have undergone procedures with these kits should consult their healthcare providers if they have concerns.
The recalled product
- Product
- CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
- Manufacturer
- American Contract Systems Inc
- Affected units
- 91
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 (11)
- Lot Code: UDI: 191072216984
- Lot Cocdes: 71-052536
- Exp: 10/30/2025
- 71-051491
- Exp: 07/16/2025
- LOT: 71-051609
- Exp: 07/30/2025
- 71-051767
- Exp: 08/14/2025
- 71-053065
- Exp: 12/10/2025
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- 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
Similar recalls
- HighCraniotomy and shunt packs recalled over unjustified sterilization of certain components
FDA (Devices) · 2025-09-03
- HighMedical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss
FDA (Devices) · 2025-03-26
- HighKnee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
- HighSurgical Procedure Kits Recalled Due to Improper Sterilization
FDA (Devices) · 2024-02-07
- HighMedical Procedure Kit Recalled Over Potential Sterilization Compromise
FDA (Devices) · 2024-08-14
- HighLaparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
FDA (Devices) · 2025-09-03