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Medical convenience kits recallZ-0173-2026 · American Contract Systems Inc. · initiated Sep 4, 2025

Class II Open, Classified All recalls posted in October 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recall details

Recall number
Z-0173-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
American Contract Systems Inc.
Quantity
32,433 total
Product code
MLS
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Product description

Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK

Code information (models, lots, serial numbers)

AHLD15X UDI-DI 191072224767 Lot 8188711 Bag serial no. 17555039 17555044 17555049 17609166 17609181; AKDV96B UDI-DI 191072224019 Lot 7311311 Bag serial no. 47140875 47141919; EVBH28D UDI-DI 191072239051 Lot 8424611 Bag serial no. 17754395; UPVD01K UDI-DI 191072238993 Lot 8439111 Bag serial no. 17682598 Log 8499211 Bag serial no. 17742543

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97659).

Sources and updates

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