Smiths Medical ASD, Inc. Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot G651610.
Products Sold
Lot G651610.
Smiths Medical ASD, Inc. is recalling Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; pro due to The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated 4/26/05.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, GA, IL, IN, MN, MO, NM, NC
Page updated: Jan 10, 2026