Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Smiths Medical ASD Inc.

Smiths Medical ASD Inc. Recalls

All product recalls associated with Smiths Medical ASD Inc..

Get alerts for this brand

Recall Summary

Total Recalls

559

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 559 recalls

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.

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.

FDAMay 29, 2024Nationwide• 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 III

1 2 345 6...28

Page 4 of 28Next

Low

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

Smith & Nephew Inc: smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 713432...

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

FDAApr 24, 2024Nationwide• Smith & Nephew Inc

Smith & Nephew Medical, Ltd.: RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated fo...

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

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

Smith & Nephew Medical, Ltd.: RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated fo...

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

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

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.

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

Smiths Medical Asd Inc: HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number...

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.

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Smiths Medical Asd Inc: Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Smiths Medical Asd Inc: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Nu...

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Smiths Medical Asd Inc: Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number...

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc

Smiths Medical Asd Inc: 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Num...

FDANov 10, 2023Nationwide• Smiths Medical Asd Inc