Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The… — Class II medical device recall Z-1396-2016
Terminated recall by Bard Peripheral Vascular Inc, reported 2016-04-20, distributed in CA, CO, FL, GA, IA, KS, MA, MI…. Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have
| Recall number | Z-1396-2016 |
|---|---|
| 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 | 2016-02-04 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-08-03 |
| Distributed | CA, CO, FL, GA, IA, KS, MA, MI, MO, MT, NV, OH, PA, PR, SC, TN, TX, VA, WA |
| Countries outside the US | AT, BR, CA, CN, CY, ES, FR, GB, NL, NO, PT |
| Quantity | 2,320 units |
| Lot numbers | REWL0924, REXA1695, REXB1529, REXC1632 |
| Model numbers | C2016B |
Product
Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Reason for recall
Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.
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-1396-2016. 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.