Data Foundry

Medical device recalls 2025

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE… — Class I medical device recall Z-0070-2026

Ongoing recall by B BRAUN MEDICAL INC, reported 2025-10-29, distributed nationwide. The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial a

Recall numberZ-0070-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmB BRAUN MEDICAL INC, Allentown, PA, United States
Recall initiated2025-09-30
Classified2025-10-22
Reported by FDA2025-10-29
DistributedNationwide (US)
UPC / GTIN / UDI-DI04046964367786
Lot numbersA2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181, A2500182, A2500185, A2500198, A2500199, A2500200, A2500203, A2500204, A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249 and 21 more
Model numbersSL-2010M2096

Product

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

Reason for recall

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

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-0070-2026. 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.