Notice names this product. DeRoyal Industries’s REF is named in FDA Class II recall Z-3256-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. Identifying details: DI: 00749756046077/Lot # 63426754. Units affected: 7 cases, 140 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
REF
Company / brand
DeRoyal Industries
Lot / serial / date codes
DI: 00749756046077/Lot # 63426754
Distribution
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Agency product description and boundaries
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.