Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Radiology Pack
- Model numbers
- LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347, Lot 8025211
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The LKRA40G Radiology Pack is a medical convenience kit used in radiology settings. Such kits support imaging processes and may contain sterile instruments or related supplies.
Why This Is Dangerous
The product was re-gassed after EO sterilization nonconformance. Multiple sterilization cycles have not been validated, risking compromised sterility and safety.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate use cessation required; potential safety risk to patients and staff if sterility is compromised.
Practical Guidance
How to identify if yours is affected
- Locate model LKRA40G UDI-DI 191072189691 and Lot 8025211.
- Check bag serial number 68154347 or note N/A indicating entire lot.
- Refer to FDA recall Z-0182-2026 for official details.
Where to find product info
FDA enforcement page linked in recall notice; product labeling and hospital procurement records
What timeline to expect
Refund or replacement timing not specified; typical recall processing ranges 4-8 weeks depending on manufacturer
If the manufacturer is unresponsive
- Escalate to FDA recall liaison
- File report with hospital risk manager
- Keep documentation of all communications
How to prevent similar issues
- Ensure sterilization processes are validated for all cycles
- Prefer single-cycle sterilization validated products
- Verify EO sterilization parameters before procurement
Documentation advice
Retain packaging, labels, serial numbers, purchase records, and all correspondence with manufacturer
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Product Details
Product: LKRA40G Radiology Pack. Brand: American Contract Systems. Model: LKRA40G UDI-DI 191072189691. Lot: 8025211. Bag serial: 68154347 (or N/A indicates entire lot). Quantity: 32,433. Distribution: United States (SD, IA, MN, WA, IL). Recall date: 2025-09-04. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents reported in the provided data.
Key Facts
- 32,433 total units recalled
- Re-gassed after EO sterilization nonconformance
- Not validated for multiple sterilization cycles
- US distribution across SD, IA, MN, WA, IL
- Recall issued 2025-09-04; FDA enforcement report Z-0182-2026
- Stop use immediately; contact provider or manufacturer
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Safety Guide
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