FDA Medical devices recall ·
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recall
- Recall number
- Z-3256-2026
- Date
- (initiated August 20, 2026)
- Company / brand
- DeRoyal Industries Inc
200 Debusk Ln, Powell, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 cases, 140 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Why was it recalled?
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DI: 00749756046077/Lot # 63426754
Distribution
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
States: Louisiana Maryland Missouri Tennessee Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3256-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.