Bard Medical SureStep Foley Tray System — Class II medical device recall Z-2154-2024
Ongoing recall by C.R. Bard Inc, reported 2024-06-26, distributed nationwide. Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being
| Recall number | Z-2154-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2024-05-09 |
| Classified | 2024-06-18 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 6,420 devices |
| UPC / GTIN / UDI-DI | 00801741024450, 00801741073861, 10801741024457, 10801741073868 |
| Lot numbers | NGHX2932, NGHZ1757 |
| Model numbers | 319416AM, A319416AM |
| Expiration dates | 2025-05-31, 2026-01-31 |
Product
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
Reason for recall
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2154-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.