Z-0178-2026Class II
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
American Contract Systems, Inc. / initiated 2025-09-04 / Open, Classified / root cause: manufacturing process
American Contract Systems Inc. began a recall of Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0178-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
- Product code
- OGR Ear, Nose, And Throat Surgical Tray
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- 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.
- Quantity in commerce
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Product codes and lots
- RCEN25B UDI-DI 191072225115 lot 8138311 bag serial number N/A; RCHN27D UDI-DI 191072235923 lot 8508211 bag serial number 47847459 * If bag serial number is listed as "n/a", then entire lot is affected
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0170-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0171-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0172-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0173-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0174-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0175-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0176-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0177-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0178-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0179-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0180-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0181-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0182-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0183-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0184-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0185-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0186-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0187-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.