CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Basic Biopsy Tray recalled by American Contract Systems
American Contract Systems is recalling Basic Biopsy Tray, distributed nationwide in the US. The recall was initiated on 4 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0170-2026
- FDA event ID
- 97659
- Recalling firm
- American Contract Systems, Grimes, IA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2025
- FDA classified
- 16 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 4 Sep 2025 | Recall initiated by company | |
| 16 Oct 2025 | Classified by FDA | +42 days |
| 22 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Basic Biopsy Tray, Item Number NMBP44L
Where it was distributed
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
Where was it sold?
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 97659This product is part of a recall event; the main page for the event is Medical convenience kits recalled by American Contract Systems.
More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |