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Open, Classified

Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

FDA Recall Z-0182-2026 · Posted 2025-10-16

Recalling FirmAmerican Contract Systems Inc.
Recall StatusOpen, Classified
Product CodeOIP
Date Initiated2025-09-04
Product Quantity32,433 total

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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