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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

232

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 201–220 of 232 recalls

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

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.

FDA

1...9 101112

Page 11 of 12Next

Sep 29, 2006

Nationwide

• 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

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: 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

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. 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

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 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: 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: 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: 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

Bard Peripheral Vascular Inc: Bard TruGuide Coxail Biopsy Needle with Depth Stop and ad...

Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.

FDAMay 1, 2006CA, FL, IN +4 more• Bard Peripheral Vascular Inc

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

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

Bard Peripheral Vascular Inc: Bard Luminexx 3 Biliary Stent and Delivery System

Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures.

FDAJul 21, 2005Nationwide• Bard Peripheral Vascular Inc

Smith & Nephew, Inc., Endoscopy Div.: Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (...

Drill does not contain laser etched depth marks to assure proper depth of inserted device

FDAJul 1, 2005NC, PR• Smith & Nephew, Inc., Endoscopy Div.