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Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. Recalls

All product recalls associated with Smiths Medical ASD, Inc..

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Recall Summary

Total Recalls

257

Past Year

9

Class I (Serious)

0

Most Recent

Apr 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 141–160 of 257 recalls

Smiths Medical ASD, Inc.: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm...

The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

FDADec 15, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube...

Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

FDANov 17, 2006NY• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Level 1 Normothermic I.V. Fluid Administration Set REF D-...

IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.

1...6 789 10...13

Page 8 of 13Next

Nationwide

• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex Continuous Epidural tray Ref 4948-17

Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

FDAOct 27, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm,...

Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

FDAAug 31, 2006AR, CA, GA +7 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D....

The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

FDAAug 11, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: STS-400 Level1 Skin Temperature Sensor with 400 Series Th...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: TTS-400J Level1 Tympanic Temperature Sensor with 400 Seri...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula R...

Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

FDAMar 7, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hy...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: A1378-18 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4903 Glass L.O.R. Syringe

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: A3176-18 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4954-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4904 Glass L.O.R. Syringe

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: A1967-18 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4902 Glass L.O.R. Syringe

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4950-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4954-16 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.