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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 41–60 of 257 recalls

CADD Medication Cassette Reservoir (Smiths Medical) – Weld Joint Weakness (2024)

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

CADD-Solis Battery Pack (Smiths Medical) – Adapter Damage Risk (2024)

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

FDAJun 26, 2024Nationwide• Smiths Medical ASD, Inc.

ENT Reservoir Kit (Smiths Medical) – Weld Joint Weakness (2024)

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FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

BLUselect Tracheostomy Tube (Smiths Medical) - Balloon Disconnection (2024)

There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.

FDAJun 7, 2024Nationwide• Smiths Medical ASD Inc.

BLUperc Procedural Tray (Smiths Medical) - Balloon Disconnection (2024)

FDAJun 7, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical Portex BLUgriggs Trays (Smiths Medical) – Pilot Balloon Disconnect (2024)

FDAJun 7, 2024Nationwide• Smiths Medical ASD Inc.

Pneupac paraPAC Plus 300 Ventilator (Smiths Medical) – Tidal Volume Knob Risk (2024)

There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

paraPAC 300 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

Pneupac paraPAC Plus 310 Ventilator (Smiths Medical) – Tidal Volume Knob Risk (2024)

There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

paraPAC Plus 310 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a...

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

FDAMay 29, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGH...

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

FDAMay 29, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intende...

CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Ind...

Laceration Risk

The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical Pneupac paraPAC plus 310 ventilator kit wi...

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

FDAFeb 7, 2024Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical Medfusion Model 3500 Syringe pump

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Smiths Medical Medfusion Guide Barrel Clamp, Item number ...

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical Medfusion Model 4000 syringe pump

Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Smiths Medical Model 3010 Syringe pumps: a. Protege Mod...

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Smiths Medical Medfusion Model 3500 Syringe pumps, Item N...

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.