EnCor Breast Biopsy Probes — Class II medical device recall Z-2210-2019
Terminated recall by Bard Peripheral Vascular Inc, reported 2019-08-14, distributed nationwide. There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while
| Recall number | Z-2210-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2019-05-02 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2022-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, JP, KR, KW, LU, MY, NL, NO, NZ, PL, PT, QA, RU, SA, SE, SG, TR, TW, VN, ZA |
| Quantity | 29,918 units |
| Reason classes | packaging |
| Lot numbers | VTCT0273, VTCT0308, VTCT0309, VTCU0351, VTCU0352, VTCW0451, VTCW0452, VTCW0453, VTCX0485, VTCX0486, VTCX0487, VTCY0548, VTCY0549, VTCY0550, VTCZ0642, VTCZ0643, VTCZ0644, VTCZ0645 |
| Model numbers | 10GV, ECP0110GV |
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Reason for recall
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
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-2210-2019. 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.