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Medline Industries, Inc. ACC010381CRecalls & reported problems

Medline Industries, Inc. · NEWBORN RESUSCITATION KIT · 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. Jul 25, 2025Class IOpen, Classified

    Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.

    Z-2567-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

  2. Feb 24, 2025Class IOpen, Classified

    Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

    Z-1505-2025 · Root cause: Process change control · Recall details · FDA record ↗

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Sources and updates

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