REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal Industries Inc · Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Open FDA's page for this record- Cfres ID
- 222404
- Product res number
- Z-3256-2026
- Event date initiated
- 2026-08-20
- Event date posted
- 2026-09-22
- Recall status
- Open, Classified
- Res event number
- 99728
- Product code
- FLL
- Product description
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- Code info
- DI: 00749756046077/Lot # 63426754
- Firm FEI number
- 1043214
- Recalling firm
- DeRoyal Industries Inc
- Address 1
- 200 Debusk Ln
- City
- Powell
- State
- TN
- Postal code
- 37849-4703
- Additional info contact
- Ms. Theresa Marsee 865-938-7828
- Reason for recall
- Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
- Root cause description
- Under Investigation by firm
- Product quantity
- 7 cases, 140 units
- Distribution pattern
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- 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 your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us 4) If you have questions regarding the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-6206 or email us at recalls@deroyal.com
- K numbers
- K925792
- Harmonized identifiers (openFDA)
- Device name
- Continuous Measurement Thermometer
- Medical specialty description
- General Hospital
- Regulation number
- 880.2910
- Device class
- 2
- K number
- K853551, K830819, K993950, K912650, K954523, K823066, K213485, K832135, K201582, K101253, K801366, K963276, K110956, K102947, K153146, K813459, K851147, K904955, K122520, K172427, K854349, K051422, K112289, K131210, K821436, K102718, K171182, K191570, K880578, K180131, K240333, K952541, K211352, K222311, K993116, K874521, K251160, K874514, K042653, K091676 +758 more
- Registration number
- 3000126629, 3021635975, 2031508, 1921846, 3001124136, 3027256461, 3028172072, 3003903031, 3030626857, 3016618143, 1018233, 1450758, 1054421, 3009831876, 3003965134, 3017894657, 1043214, 8022257, 3018188848, 2082313, 3016075711, 3005785090, 3016850322, 3028019184, 1066444, 3015142935, 3017887928, 3003263092, 3042156936, 3009124884, 9610816, 3015276780, 9617601, 3016452327, 1000122786, 9616085, 3013826848, 3037724692, 3006142663, 2320762 +445 more
- FEI number
- 3000126629, 3004631140, 3021635975, 1921846, 3003757840, 3001124136, 3027256461, 3028172072, 3003903031, 3030626857, 3016618143, 1018233, 1450758, 3009831876, 3003965134, 3017894657, 1043214, 3018188848, 2082313, 3016075711, 3005785090, 3016850322, 3028019184, 3015142935, 3017887928, 3006469671, 3003263092, 3042156936, 3005479955, 3009124884, 3015276780, 3016452327, 1000122786, 3013826848, 3037724692, 3006142663, 2434115, 3021343210, 3006140792, 3043513123 +445 more