Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
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 FDA Class II recall involves surgical packs with unvalidated sterilization, which poses a potential infection risk to patients. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, meeting the rubric criteria for High (Score 3) severity.
Plain-English summary
American Contract Systems is recalling certain obstetric and gynecology surgical packs (15 units total) distributed to health systems and medical device distributors in multiple U.S. states. These packs are used in surgical procedures and must maintain strict sterilization to ensure patient safety.
The recalled products were exposed to multiple sterilization cycles without validation or testing to confirm the packs remained safe and sterile after multiple exposures. This lack of validation could compromise the sterility integrity of the surgical instruments, potentially increasing infection risk for patients undergoing procedures.
The affected packs were distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Detailed identification information including tray numbers, sterilization lots, and batch serial numbers is available in the FDA's official recall notice. No illnesses or injuries related to these packs have been reported.
Health systems and distributors who have received these packs should consult the FDA recall notice and contact American Contract Systems for guidance on product disposition and replacement.
The recalled product
- Product
- Various ob/gyn packs
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- unvalidated-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 (20)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSROBDELIVC
- 2104091
- 904211
- 14531604 2) LSRVAGDELIVC
- 2106011
- 863211
- 44252284 3) LSRVAGDELIVC
- 44135283 4) LSRCFHVAGDC
- 2108042
- 791211
- 64123598 5) LSRCFHVAGDC
- 64123599 6) LSRCFHVAGDC
- 64123597 7) LSRVAGDELIVC
- 2108181
- 776211
- 44139780 8) LSROBDELIVC
- 2109231
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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