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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

Class I (Serious)

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 161–180 of 257 recalls

Smiths Medical ASD, Inc.: 4950-16 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.: A2549-22 Spinal Needle

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.

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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.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Instructions for use included in the package are for a different tracheostomy tube.

FDAJul 25, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,...

Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

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

Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G ...

Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"

FDAMay 5, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm trac...

The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

FDAApr 26, 2005CT, GA, IL +5 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult ...

The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

FDAApr 19, 2005CA, IN, NC• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, pr...

The word PED was printed on the neckflange instead of the word NEO.

FDAFeb 17, 2005GA, IL, IN +4 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Equator Forced Air Convective Warming System, Reference N...

Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

FDADec 15, 2004Nationwide• Smiths Medical ASD, Inc.