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Smiths Medical MD, Inc.

Smiths Medical MD, Inc. Recalls

All product recalls associated with Smiths Medical MD, 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 381–400 of 573 recalls

Smiths Medical MD, Inc.: Smiths CADD Medication Cassette Reservoirs with Clamp and...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Yellow Medication Cassette Reservoirs with Cl...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Smith And Nephew, Inc. Wound Management Division: Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Produc...

Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.

FDANov 21, 2007Nationwide

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• Smith And Nephew, Inc. Wound Management Division

Smiths Medical Asd Inc: Smiths Medical, Add-On Kids Kit , Blood Sampling System,...

Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device

FDANov 21, 2007Nationwide• Smiths Medical Asd Inc

Smiths Medical ASD, Inc.: Portex Perfit Percutaneous Tracheostomy Tube Replacement ...

Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

FDASep 18, 2007Nationwide• Smiths Medical ASD, Inc.

Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, ...

Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

FDAAug 21, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smiths Medical MD, Inc.: Smiths Medical CADD-Sentry Pro Medication Safety Software...

Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.

FDAAug 14, 2007CO, MD, UT• Smiths Medical MD, Inc.

Smiths Medical PM, Inc.: BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor,...

Phantom pacer spikes caused by a damaged resistor.

FDAJul 18, 2007KY, LA, MS +2 more• Smiths Medical PM, Inc.

Smith & Nephew Inc: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cu...

The carton label may not reflect the correct size of the acetabular cup.

FDAJul 12, 2007Nationwide• Smith & Nephew Inc

Smiths Medical MD, Inc.: Smiths CADD Yellow Medication Cassette Reservoir, With cl...

Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.

FDAJun 18, 2007PR• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Medication Cassette Reservoir, With clamp and...

FDAJun 18, 2007PR• Smiths Medical MD, Inc.

Smiths Medical PM, Inc.: BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

FDAJun 5, 2007PR• Smiths Medical PM, Inc.

Smiths Medical PM, Inc.: Pneupac VR1 Standard and VR1 Responder is a hand held por...

Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.

FDAMay 16, 2007Nationwide• Smiths Medical PM, Inc.

Smith & Nephew, Inc Endoscopy Division: Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for e...

Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.

FDAApr 9, 2007IN• Smith & Nephew, Inc Endoscopy Division

Smith & Nephew Inc: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cu...

The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

FDAMar 13, 2007Nationwide• Smith & Nephew Inc

Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew Suture Passer 2 inch Part Number : 7209167

Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.

FDAMar 1, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew Suture Passer 12 inch Part Number: 7209166

Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.

FDAMar 1, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smiths Medical MD, Inc.: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medi...

Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

FDAFeb 3, 2007Nationwide• Smiths Medical MD, Inc.

Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 5cm, temperature sensing electrodes...

Product is non-sterile but labeled incorrectly as sterile.

FDAJan 19, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc Endoscopy Division: SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #7...

Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

FDAJan 19, 2007Nationwide• Smith & Nephew, Inc Endoscopy Division