Data Foundry

Medical device recalls 2026

Broviac 4 — Class II medical device recall Z-1367-2026

Ongoing recall by Bard Peripheral Vascular Inc, reported 2026-02-25, distributed nationwide. Due to damage to outer tray that can potentially compromise the sterile barrier

Recall numberZ-1367-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2025-12-12
Classified2026-02-13
Reported by FDA2026-02-25
DistributedNationwide (US)
Countries outside the USAR, AU, BR, CA, CL, HK, IN, JP, KR, MX, MY, SG, TH, UY, VN
Quantity14,935 units
Reason classessterility
UPC / GTIN / UDI-DI00801741051692, 00801741051708, 00801741051715, 00801741051739, 00801741051777, 00801741051807, 00801741051821, 00801741051845, 00801741051869, 00801741051913, 00801741051975, 00801741052019
Lot numbersHUJY0302, HUJY1095, HUJZ1332, HUJZ1336, HUJZ1339, HUJZ1340, HUKQ0535, HUKR0064, HUKR0065, HUKR0067, HUKR1342, HUKR1344, HUKR1346, HUKR1347, HUKR1348, HUKR1349, HUKR1356, HUKR1359, HUKR1363, HUKR1364, HUKR1367, HUKR1368, HUKR1370, HUKS0774, HUKS0776, HUKS0783, HUKS0784, HUKS0806, HUKS0811, HUKS0816, HUKS1217, HUKS1218, HUKS1219, HUKS1220, HUKS1468, HUKS1474, HUKS1483, HUKU0238, HUKU0242, HUKU0246 and 70 more
Model numbers0600100CE, 0600310CE, 0600520CE, 0600540CE, 0600560CE, 0600570CE, 0600620CE, 0600650CE, 0606560CE, 600060, 600100, 600120, 600310, 600350, 600520, 600540, 600560, 600570, 60060, 600620, 600650, 606560

Product

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

Reason for recall

Due to damage to outer tray that can potentially compromise the sterile barrier

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-1367-2026. 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.