Data Foundry

Medical device recalls 2024

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK — Class II medical device recall Z-1771-2024

Ongoing recall by Angiodynamics, Inc., reported 2024-05-15, distributed in VA. Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, pos

Recall numberZ-1771-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAngiodynamics, Inc., Queensbury, NY, United States
Recall initiated2024-03-18
Classified2024-05-03
Reported by FDA2024-05-15
DistributedVA
Quantity15 units
Reason classesforeign material
UPC / GTIN / UDI-DI25051684011850
Lot numbers5807208

Product

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

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-1771-2024. 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.