FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- Recall number
- Z-3256-2026
- Recalling firm
- DeRoyal Industries Inc
- Product
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- Status
- Open, Classified
- Initiated
- 2026-08-20
- Posted
- 2026-09-22
- Terminated
- not on file
- 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 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
- Quantity
- 7 cases, 140 units
- Distribution
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- Lot, serial or model codes
- DI: 00749756046077/Lot # 63426754
- 510(k) numbers
- ["K925792"]
- PMA numbers
- not on file
- Product code
- FLL
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28