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
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
- Labor Delivery Pack / Birthing Room Pack
- Model numbers
- AHLD15X UDI-DI 191072224767 Lot 8188711, AKDV96B UDI-DI 191072224019 Lot 7311311, EVBH28D UDI-DI 191072239051 Lot 8424611, UPVD01K UDI-DI 191072238993 Lot 8439111
- 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
Labor and delivery packs are bundled sterile supplies used during childbirth in hospital settings. They include items needed for vaginal delivery and birthing room procedures. Hospitals rely on validated sterilization to ensure patient safety.
Why This Is Dangerous
The key issue is re-gassing after a nonconformance in EO sterilization. The packs have not been validated for exposure to multiple sterilization cycles, which could compromise sterility and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to replace affected packs and may experience temporary disruption in stock. The recall could affect patient safety if sterility is not guaranteed.
Practical Guidance
How to identify if yours is affected
- Identify model numbers AHLD15X, AKDV96B, EVBH28D, UPVD01K on the packaging and labels
- Compare with the recall notice for confirmation
Where to find product info
Recall letter from American Contract Systems and FDA recall page under Z-0173-2026
What timeline to expect
Refund or replacement processing typically 4-6 weeks after verification of eligibility
If the manufacturer is unresponsive
- File a consumer complaint with the FDA/CBSA if applicable
- Ask hospital procurement for assistance and escalation to manufacturer
How to prevent similar issues
- Only rely on sterilization processes validated by EO gas suppliers
- Source sterile packs from reputable manufacturers
- Maintain clear records of lot and serial numbers for recall notices
Documentation advice
Keep the recall letter, take photos of labels and packaging, record model/UDI/Lot numbers, save all correspondence with supplier
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Product Details
Brand: American Contract Systems. Affected products include AHLD15X Labor Delivery Pack (213387), AKDV96B Vaginal Delivery, EVBH28D Birthing Room Pack, UPVD01K Vaginal Delivery Pack. Each model lists a UDI-DI and Lot number: - AHLD15X UDI-DI 191072224767 Lot 8188711 - AKDV96B UDI-DI 191072224019 Lot 7311311 - EVBH28D UDI-DI 191072239051 Lot 8424611 - UPVD01K UDI-DI 191072238993 Lot 8439111 Distribution: US nationwide, including SD, IA, MN, WA, IL Quantity: 32,433 units Sold/Price: Not disclosed Country of origin: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- 4 models affected: AHLD15X, AKDV96B, EVBH28D, UPVD01K
- Models list with UDI-DI and Lot numbers provided
- EO gas re-gassing identified as root issue
- US nationwide distribution with state mentions SD, IA, MN, WA, IL
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Safety Guide
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