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Medline Industries, Inc. DYNJ907914BRecalls & reported problems

Medline Industries, Inc. · DEBOER HEART · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. May 4, 2026Class IIOpen, Classified

    During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

    Z-2487-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  2. May 18, 2023Class IIOpen, Classified

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

    Z-2166-2023 · Root cause: Device Design · Recall details · FDA record ↗

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Sources and updates

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