Product Wiki · Recalls · U.S. FDA — Device Enforcement

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model… — recall Z-2092-2026

U.S. FDA — Device Enforcement · United States · 2026-01-07 · Class II

As described by U.S. FDA — Device Enforcement: Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A;

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2092-2026
Date of alert
2026-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries, LP
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide - US Nationwide distribution.
Barcode (EAN/GTIN)
10198459089169
Reported risk: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.