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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

573

Past Year

Class I (Serious)

Most Recent

Nov 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 61–80 of 573 recalls

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.

High

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

PORTEX Bivona Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

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.

High

FDAMay 29, 2024Nationwide• Smiths Medical ASD Inc.

Pediatric Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

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.

High

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Page 4 of 29Next

FDA

May 29, 2024

Nationwide

• Smiths Medical ASD Inc.

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

Class IIILow

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

OXINIUM Femoral Head (Smith & Nephew) – Size Mismatch (2024)

Packaging contained the incorrect size of femoral head from what was displayed on the label.

Low

FDAApr 24, 2024Nationwide• Smith & Nephew Inc

RENASYS EDGE 300ML Canister (Smith & Nephew) – Carbon Filter Contamination (2024)

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Moderate

FDAMar 11, 2024Nationwide• Smith & Nephew Medical, Ltd.

RENASYS EDGE 800ML Canister (Smith & Nephew) – Carbon Filter Contamination (2024)

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Moderate

FDAMar 11, 2024Nationwide• Smith & Nephew Medical, Ltd.

CADD-Solis Ambulatory Pumps (Smiths Medical) – Software Malfunction (2024)

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.

Moderate

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

CADD-Solis VIP Pumps (Smiths Medical) – Infusion Uses (2024)

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.

Moderate

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

paraPAC Plus Ventilator (Smiths Medical) – Gas Flow Problem (2024)

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.

Moderate

FDAFeb 7, 2024Nationwide• Smiths Medical ASD Inc.

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

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.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Barrel Clamp (Smiths Medical) – pump component risk (2023)

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.

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion 4000 Pump (Smiths Medical) – software alarm issue (2023)

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.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Anoro Ellipta Inhaler (GSK) – Release Testing Failure (2023)

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

Class IIILow

FDADec 12, 2023Nationwide• GlaxoSmithKline LLC

High Pressure Rotator (Smiths Medical) – O-ring Size (2023)

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Moderate

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Stay Informed

Smiths Medical ASD Inc. Recalls

Recall Summary

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

PORTEX Bivona Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

Pediatric Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

OXINIUM Femoral Head (Smith & Nephew) – Size Mismatch (2024)

RENASYS EDGE 300ML Canister (Smith & Nephew) – Carbon Filter Contamination (2024)

RENASYS EDGE 800ML Canister (Smith & Nephew) – Carbon Filter Contamination (2024)

CADD-Solis Ambulatory Pumps (Smiths Medical) – Software Malfunction (2024)

CADD-Solis VIP Pumps (Smiths Medical) – Infusion Uses (2024)

paraPAC Plus Ventilator (Smiths Medical) – Gas Flow Problem (2024)

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion Barrel Clamp (Smiths Medical) – pump component risk (2023)

Medfusion 4000 Pump (Smiths Medical) – software alarm issue (2023)

Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Medfusion Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Anoro Ellipta Inhaler (GSK) – Release Testing Failure (2023)

High Pressure Rotator (Smiths Medical) – O-ring Size (2023)

Medex Stopcock (Smiths Medical) – O-ring Size (2023)

Injection Line Adapter (Smiths Medical) – O-ring Size (2023)

Braided Injection Line (Smiths Medical) – O-ring Size (2023)