TTS-400J Level1 Tympanic Temperature Sensor with 400 Series… recallZ-0768-06 · Smiths Medical ASD, Inc. · initiated Mar 8, 2006
Terminated All recalls posted in April 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product temperature readings may be 2C higher than the actual temperature
FDA root cause category: Other
What the company is doing
Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement.
Recall details
- Recall number
- Z-0768-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 8, 2006
- Posted by the FDA
- Apr 18, 2006
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 400
- Product code
- FLL
- FDA submissions
- K864195
- Distribution
- Nationwide, Canada, France, Japan, Netherlands
Product description
TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
Code information (models, lots, serial numbers)
Lot Number: 3080
Other devices under the same FDA submission
1 device cleared under K864195 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Level 1 STS-400Icu Medical, Inc. · Thermometer, electronic, clinical1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 34844).
- Z-0767-06 · TerminatedSTS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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