Data Foundry

Medical device recalls 2025

Convenience kits — Class I medical device recall Z-0451-2026

Ongoing recall by Medline Industries, LP, reported 2025-11-19, distributed nationwide. Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cra

Recall numberZ-0451-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2025-10-10
Classified2025-11-13
Reported by FDA2025-11-19
DistributedNationwide (US)
Countries outside the USMX, PA
Quantity96,406 units
Reason classespackaging
UPC / GTIN / UDI-DI10198459130458, 10198459130465, 10198459130489, 10198459130595, 10198459130793, 40198459130459, 40198459130466, 40198459130480, 40198459130596, 40198459130794
Lot numbers25FBB321, 25FBE036, 25FBO307, 25FBR230, 25GBN625, 25GBU688, 25GBU693, 25GBV759, 25IBM788

Product

Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

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-0451-2026. 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.