Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2114-2018·Announced 2018-06-13

Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Sterility Labeling Error

Smiths Medical ASD Inc. is recalling 16 Bivona Tracheostomy Tubes because the cartons are labeled 'Sterile' even though the devices are not sold as sterile.

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: This is classified as a Moderate severity recall (Score 2) because it involves a minor labeling error regarding sterility status, which is a documentation issue rather than a direct physical defect or contamination.

Plain-English summary

Smiths Medical ASD Inc. is recalling 16 units of Bivona Tracheostomy Tubes. The recall was initiated because the carton labeling incorrectly indicates that the devices are 'Sterile,' although the devices are not sold as sterile.

The affected units were distributed domestically to California, Florida, Georgia, Idaho, New Jersey, New Mexico, Ohio, and Virginia, as well as internationally to France. Specific part and lot numbers are listed in the official recall documentation.

Consumers and healthcare facilities should check their inventory for the specific part and lot numbers associated with this recall. If the affected units are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product: Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Tracheostomy Tubes
Hazard: mis-labeling
Affected units: 16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

Part No. (Lot No.): CMZ3241N (DS009716)
ST16EN80NSC194N (DS009794)
SU15AN70NSC153N (DS009577)
FT17IN60NGC114N (DS009894)
CMZ3331N (DS009761)
XU17GS50NSF046N (DS009609)
FT17IN60NGC114N (DS009861)
AA16ES70NSC110N (DS009586)
FT17IN70NSC111N (DS009856)
FT16IN60NGC053N (DS009540)
FU15AN55NSA076N (DS009464)
AT17IS60NGC105N (DS009811)

Distribution

Distributed in 8 states:

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · mis labeling