BD Recanalization System — Class II medical device recall Z-0676-2024
Ongoing recall by Bard Peripheral Vascular Inc, reported 2024-01-17, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the t
| Recall number | Z-0676-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2023-11-14 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, PA, PR, TX, VA, WI |
| Quantity | 403 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00801741202421 |
| Serial numbers | BSX000001, BSX000002, BSX000003, BSX000004, BSX000005, BSX000006, BSX000007, BSX000008, BSX000009, BSX000010, BSX000011, BSX000012, BSX000013, BSX000014, BSX000015, BSX000016, BSX000017, BSX000018, BSX000019, BSX000020, BSX000021, BSX000022, BSX000023, BSX000024, BSX000025 and 378 more |
Product
BD Recanalization System, REF: BDRECANSYSTEM
Reason for recall
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
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-0676-2024. 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.