Edan iT20 Telemetry Transmitter Recalled for Uncleared Function
Edan Diagnostics is recalling 7 iT20 telemetry transmitters because they include a function not cleared by the U.S. FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (uncleared function) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Edan Diagnostics is recalling 7 units of the EDAN Telemetry Transmitter, Model iT20. The firm identified that these specific units were distributed in the United States with a function that has not been cleared by the U.S. Food and Drug Administration.
The affected devices are intended for use in clinical divisions of hospital environments, including coronary care units (CCU) and general wards. The recall covers 7 units distributed nationwide, specifically within the state of California. The specific serial numbers for the affected units are 260638-M16400850001, 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 261350-M17A03030001, and 261350-M17A03030002.
Healthcare facilities should check their inventory for these specific serial numbers. If an affected unit is found, it should be removed from service and returned to Edan Diagnostics for further instructions.
The recalled product
- Product
- EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
- Manufacturer
- Edan Diagnostics
- Affected units
- 7
Distribution
Related recalls
Same manufacturer · Edan Diagnostics
See all →- ModerateFetal and maternal monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- HighEndoluminal vision probe bags recalled over compromised sterile pouch seals
FDA (Devices) · 2026-01-28
- ModerateiM8 series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateiM3s series vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateM3 vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateTelemetry transmitters recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28
- HighEdan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings
FDA (Devices) · 2016-08-17
- ModerateiM20 patient monitors recalled over potential cybersecurity issues flagged by FDA
FDA (Devices) · 2026-01-28
- HighElana Catheter Sizer 2.0 Recalled for Unapproved Distribution
FDA (Devices) · 2013-04-24
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- HighIrvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error
FDA (Devices) · 2020-09-30