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Smith & Nephew, Inc Endoscopy Division

Smith & Nephew, Inc Endoscopy Division Recalls

All product recalls associated with Smith & Nephew, Inc Endoscopy Division.

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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 401–420 of 573 recalls

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, 10 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.

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

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 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 Blue, 9mm; quantity 1; Part #60...

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

Smith & Nephew, Inc. Endoscopy Division: TruFit CB Plug Size Code Red, 7mm; 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

Smiths Medical MD, Inc.: Locator-Wand Cover that is sold in a shelf carton (unit p...

Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

FDASep 27, 2006CA, FL, MD +4 more• Smiths Medical MD, Inc.

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm,...

Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

FDAAug 31, 2006AR, CA, GA +7 more• Smiths Medical ASD, Inc.

Smith & Nephew Inc: Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers:...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Smith & Nephew Inc: Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Cat...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Smith & Nephew Inc: Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbe...

Tibial punches were not manufactured to specification and could break at the tip during use.

FDAAug 29, 2006Nationwide• Smith & Nephew Inc

Smiths Medical ASD, Inc.: Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D....

The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

FDAAug 11, 2006Nationwide• Smiths Medical ASD, Inc.