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Smiths Medical PM, Inc.

Smiths Medical PM, Inc. Recalls

All product recalls associated with Smiths Medical PM, Inc..

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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 381–400 of 559 recalls

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.

1...18 192021 22...28

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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: SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #...

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

Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 15 cm, temperature sensing electrod...

Product is non-sterile but labeled incorrectly as sterile.

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

Smiths Medical MD, Inc.: Deltec branded CADD-Prizm PCS II ambulatory infusion pump...

The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

FDAJan 19, 2007Nationwide• Smiths Medical MD, Inc.

Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 10 cm, temperature sensing electrod...

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

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

Smiths Medical ASD, Inc.: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm...

The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

FDADec 15, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube...

Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

FDANov 17, 2006NY• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Level 1 Normothermic I.V. Fluid Administration Set REF D-...

IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.

FDANov 7, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical PM, Inc.: BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Mon...

An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.

FDANov 6, 2006PR• Smiths Medical PM, Inc.

Smith & Nephew, Inc Endoscopy Division: Well Leg Holder With Boot, part of the Supine Universal H...

The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.

FDANov 1, 2006Nationwide• Smith & Nephew, Inc Endoscopy Division

Smiths Medical ASD, Inc.: Portex Continuous Epidural tray Ref 4948-17

Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

FDAOct 27, 2006Nationwide• Smiths Medical ASD, Inc.

Smith & Nephew, Inc. Endoscopy Division: TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600...

Mis-packaging-product in the package may be a different size than indicated on the labeling.

FDASep 29, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division