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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 421–440 of 573 recalls

Smith & Nephew, Inc. Endoscopy Division: TriVex 200LV Resector Kit, 5.5 Part Number: 7209271

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: 5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 p...

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: 4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 p...

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

FDA

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Page 22 of 29Next

Jun 19, 2006

Nationwide

• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: Dyonics Electroblade, 4.5 Full Radius, Valleylab Generato...

Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Ge...

Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: TriVex 100SV Resector Kit, 4.5 Part Number: 7205876

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew Hip Positioning System Ref: 72200624 with ...

The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure

FDAMay 22, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew Inc: Genesis II, Cruciate Retaining, Oxinium, Femoral componen...

Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.

FDAApr 12, 2006IN, LA, NC• Smith & Nephew Inc

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

One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.

FDAMar 29, 2006Nationwide• Smiths Medical MD, Inc.

Smith & Nephew, Inc. Endoscopy Division: FAST-FIX AB Curved Needle Delivery System, Used for menis...

The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.

FDAMar 24, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smiths Medical ASD, Inc.: TTS-400J Level1 Tympanic Temperature Sensor with 400 Seri...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: STS-400 Level1 Skin Temperature Sensor with 400 Series Th...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula R...

Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

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

Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hy...

Sterility is compromised by incomplete package seal.

FDADec 16, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical MD, Inc.: Large-Volume IV Administration Sets for use with Deltec 3...

Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

FDADec 8, 2005SC, PR• Smiths Medical MD, Inc.

Smiths Medical PM, Inc.: Smiths Pneupac babyPAC portable ventilator, model 100. D...

A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.

FDADec 5, 2005CA, CO, IN +5 more• Smiths Medical PM, Inc.

Smiths Medical ASD, Inc.: A1272-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4950-17 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: 4954-16 Portex Epidural Mini-pack

Tray may contain holes compromising the sterility of the device

FDANov 17, 2005Nationwide• Smiths Medical ASD, Inc.