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Medline Industries, Inc. DYNJ0545064AARecalls & reported problems

Medline Industries, Inc. · CATH LAB ANGIO PACK-LF · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 27, 2026Open, Classified

    Unapproved design changes to the products outside of the 510(k) clearance.

    Z-1877-2026 · Root cause: Component change control · FDA record ↗

  2. May 18, 2023Open, Classified

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    Z-2160-2023 · Root cause: Device Design · FDA record ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.