Data Foundry

Medical device recalls 2025

Medline medical procedure kits — Class I medical device recall Z-1457-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-16, distributed in CA, FL, MN, NY, OH, OR, PA, TX…. Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential exce

Recall numberZ-1457-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-02-21
Classified2025-04-04
Reported by FDA2025-04-16
DistributedCA, FL, MN, NY, OH, OR, PA, TX, WV
Quantity468 units
UPC / GTIN / UDI-DI10195327166304, 10195327273484, 10195327503390, 40195327166305, 40195327273485, 40195327503391
Lot numbers22GBL197, 22JBG283, 23ABO787, 23EBT153, 23HBB950, 24CBL126, 24EBV315, 24EBW136

Product

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Reason for recall

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

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-1457-2025. 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.