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Class IIOngoing

DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
DeRoyal Industries Inc
Reason
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99728…

Products

  1. REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

    Codes/lots: DI: 00749756046077/Lot # 63426754Quantity: 7 cases, 140 unitsRecall no. Z-3256-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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