Vaginal Delivery Medical Convenience Kit Recalled for Unconfirmed Sterilization Assurance
American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.
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 an FDA Class II recall of a medical device where sterilization assurance cannot be confirmed. With no reported illnesses or injuries, the theoretical hazard of contamination and infection scores as High (3) per the severity rubric.
Plain-English summary
American Contract Systems, Inc. is recalling the Vaginal Delivery, ASDV25B medical convenience kit. The recalled lot is 2405102, with an expiration date of May 10, 2025. Distribution includes nationwide coverage in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
The recall was initiated after discovering that an inoperable chart recorder in a controlled environment area resulted in humidity readings that were out-of-specification. As a result, the manufacturer cannot confirm that the product meets sterilization assurance requirements.
An inability to confirm sterilization of a medical device creates a potential risk of contamination and infection. Consumers in possession of this product should contact American Contract Systems, Inc. for instructions.
The recalled product
- Product
- Vaginal Delivery, ASDV25B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- unconfirmed-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 (3)
- UDI-DI: 00191072218841
- Lot: 2405102
- Exp: 05/10/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03