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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 81–100 of 257 recalls

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model: Model 4000-0100-50, Model ...

Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-...

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

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Smiths Medical ASD Inc.: Bivona Aire-Cuf Endotracheal Tube

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

FDAAug 9, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Bivona Uncuffed Wire Endotracheal Tubes,

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

FDAAug 9, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: NORMOFLO Irrigation Warming administration set (disposabl...

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

FDAAug 6, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

FDAAug 6, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical portex Tracheal Intubation Stylet, REF 100...

The incorrect device is contained in the package.

FDAAug 4, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Two devices were labeled with the same serial number

FDAJul 15, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE:...

Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.

FDAMay 17, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, ...

Laceration Risk

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

FDAMay 14, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: ACE MDI Spacer with Small Mask - Product Usage: designed ...

The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK...

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, O...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTA...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Palm Cups - Product Usage: intended to be used to percuss...

The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: LogiCal Left Heart Kit, Model Number M20553. for blood pr...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX103...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Tubing with male luer lock adapter (Component) a. 76 cm,...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Compon...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. R...

FDAMar 31, 2021Nationwide• Smiths Medical ASD Inc.