Recall archive / FDA device enforcement
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni... — FDA record Z-1424-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 31, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
- Reason
- Sterility assurance with procedure trays
- Classification
- Class II
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 800
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1424-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 2, 2025
- Recall initiation date
- Jan 31, 2025
- Center classification date
- Mar 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.