Z-0170-2026Class II
Basic Biopsy Tray, Item Number NMBP44L
American Contract Systems, Inc. / initiated 2025-09-04 / Open, Classified / root cause: manufacturing process
American Contract Systems Inc. began a recall of Basic Biopsy Tray, Item Number NMBP44L 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-0170-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- Basic Biopsy Tray, Item Number NMBP44L
- Product code
- FCH Tray, Biopsy, Without Biopsy Instruments
- 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
- UDI-DI 191072188120 Lot 8515411 Entire lot impacted
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 |
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