Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss
American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II medical device recall without reported illnesses or injuries. The hazard is theoretical—components may have lost functionality, efficacy, or accumulated elevated residuals due to unvalidated sterilization exposure—but no confirmed harm has been reported. Per the rubric, a risk-of-harm product (obstetrical kits) where injury has not yet been reported receives a score of 3.
Plain-English summary
American Contract Systems, Inc. is recalling custom procedural convenience kits and trays designed for obstetrical and gynecological use, specifically Labor and Delivery Packs (kit numbers HILD52F and HILD52G). The recall affects 114 units distributed nationwide.
During an internal investigation, the manufacturer identified that certain components were subjected to their sterilization process without proper validation. Supporting documentation was not available to confirm these components were suitable for exposure to elevated temperatures and the sterilization procedure. As a result, the components may have lost functionality, reduced efficacy, or accumulated higher than specified residual levels from the sterilization process.
These medical devices are used in labor and delivery procedures where loss of functionality or efficacy could affect patient care. The manufacturer has not reported any confirmed incidents of harm or injury related to this issue.
Affected lot numbers are: HILD52F (lots 846221, 807221, 959231) and HILD52G (lot 885231). Consumers or healthcare providers with these products should contact the manufacturer or refer to the FDA website for guidance on next steps.
The recalled product
- Product
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 114
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 (11)
- a) HILD52F
- UDI/DI none
- Lot Numbers: 846221
- exp. 6/3/2023
- 807221
- exp. 7/12/2023
- 959231
- exp. 11/30/2023
- b) HILD52G
- Lot Numbers: 885231
- exp. 4/25/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · American Contract Systems, Inc.
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · loss of functionality
See all →- HighSafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue
FDA (Devices) · 2026-07-29
- HighMedical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
FDA (Devices) · 2025-06-18
- HighBaxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment
FDA (Devices) · 2025-04-02
- HighNeuro IR Tray recalled over unconfirmed sterilization assurance
FDA (Devices) · 2025-03-26
- HighBirth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance
FDA (Devices) · 2025-03-26
Similar recalls
- HighLabor and Delivery Pack Recalled Over Unconfirmed Sterilization
FDA (Devices) · 2025-03-26
- HighLabor and delivery packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighLabor and delivery packs recalled over unconfirmed product sterilization assurance
FDA (Devices) · 2025-09-03
- HighLabor and Delivery System Recalled for Sterilization Assurance Issue
FDA (Devices) · 2025-03-26
- HighHysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements
FDA (Devices) · 2025-09-03
- HighObstetric and gynecology surgical packs recalled for unvalidated sterilization exposure
FDA (Devices) · 2022-09-14