FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
- Recall number
- Z-0768-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
- Status
- Terminated
- Initiated
- 2006-03-08
- Posted
- 2006-04-18
- Terminated
- 2012-05-30
- Reason
- Product temperature readings may be 2C higher than the actual temperature
- 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
- 400
- Distribution
- Nationwide, Canada, France, Japan, Netherlands
- Lot, serial or model codes
- Lot Number: 3080
- 510(k) numbers
- ["K864195"]
- PMA numbers
- not on file
- Product code
- FLL
- Firm FEI
- 1221261
- Firm city
- Rockland
- Firm state
- MA
- 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