Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects
American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.
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: FDA Class II medical device recall affecting surgical kits with potential loss of functionality and reduced drug efficacy. No hospitalizations or injuries have been reported. This meets the rubric criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 1,020 custom obstetrical and gynecological surgical kits distributed nationwide. The kits are used in obstetrical and gynecological procedures and come in multiple models identified by kit number (including AGLP52L, HGOB98G, HHDV17, MMGR44D, MMJL16E, SMGY46, THLH71C, UIHY16AA, and WELP67C variants).
During an internal investigation, the manufacturer identified several components that were "piggybacked" (added) to the kits and subjected to the company's sterilization process. The issue: there is no documentation confirming whether these components were assessed to determine if they were suitable for exposure to elevated temperatures and extended sterilization.
Without this assessment, the affected components may experience loss or lack of functionality, loss of drug efficacy (where applicable), or may contain higher-than-specified levels of ethylene oxide (EO) sterilization residue. These defects could affect the safety and performance of the kits during procedures.
Affected lot numbers are identified by kit number and expiration date. Users should identify the kit model number and lot number, discontinue use of affected kits, and contact American Contract Systems, Inc. for replacement or proper disposition instructions.
The recalled product
- Product
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- loss-of-functionality
- loss-of-drug-efficacy
- sterilization-residue
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)
- a) AGLP52L
- UDI/DI 00191072144119
- Lot Numbers: 933231
- exp. 3/8/2024
- 942231
- exp. 2/27/2024
- 947231
- exp. 2/22/2024
- 966231
- exp. 2/3/2024
- 980231
- exp. 1/20/2024
- 681221
- exp. 11/15/2023
- 707221
- exp. 10/20/2023
- b) HGOB98G
- UDI/DI none
- Lot Numbers: 667221
- exp. 11/29/2023
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