Z-0768-06

TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor

Name: Z-0768-06 TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
Creator: Smiths Medical ASD, Inc.
Published: 2006-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-03-08 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor on 2006-03-08. The reason FDA records is "Product temperature readings may be 2C higher than the actual temperature". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0768-06
Status: Terminated
Initiated: 2006-03-08
Posted: 2006-04-18
Terminated: 2012-05-30
Recalling firm: Abbott Medical
Product: TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
Product code: FLL Continuous Measurement Thermometer
Reason for recall: Product temperature readings may be 2C higher than the actual temperature
FDA root cause: Other
Action: Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement.
Quantity in commerce: 400
Distribution: Nationwide, Canada, France, Japan, Netherlands
Product codes and lots: Lot Number: 3080

Product code FLL

K864195Class IISurface Skin Temp Probe W/thermocouple Type TRespiratory Support Products, Inc. / cleared 1986-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)