CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalled
DeRoyal Industries is recalling REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3256-2026
- FDA event ID
- 99728
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2026
- FDA classified
- 22 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2026 | Recall initiated by company | |
| 22 Sep 2026 | Classified by FDA | +33 days |
| 30 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Where it was distributed
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Questions about this recall
Why was it recalled?
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Which lots are affected?
DI: 00749756046077/Lot # 63426754
Where was it sold?
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DeRoyal Industries
All 227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled | DeRoyal Industries | Sterility | Nationwide |
| Device | CLASS II | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled | DeRoyal Industries | Foreign Material | 5 states |
| Device | CLASS II | DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries | DeRoyal Industries | Packaging Defects | 21 states |
| Device | CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
| Device | CLASS II | DeRoyal Children's General Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |