Recall Z-3256-2026 ยท FLL Continuous Measurement Thermometer
DeRoyal Industries Inc
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
| Date | Sep 22, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| Reason | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. |
| Root cause | Under Investigation by firm |
| Action | On August 20, 2026, DeRoyal Industries Inc. issued a Urgent Medical Device Recall via Email. DeRoyal ask consignees to take the following actions: 1) Identify affected product numbers in your inventory and place in quarantine to prevent further use. 2) Please return the completed Notice of Return form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than September 15, 2026. Please complete the form even if you no longer have any inventory. 3) If you distributed this product to other facilities or departments within your institution, it is required by federal law that y |
| Quantity | 7 cases, 140 units |
| Distribution | US Nationwide distribution in the states of LA,MO, MD, TN, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925792 | EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE Deroyal Industries, Inc., Apr 8, 1994 |