111 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GDI·November 6, 2007
Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GEI·November 6, 2012
HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·March 16, 2012
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GDW·July 29, 2011
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code NLM·July 10, 2015
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code NLQ·January 19, 2021
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 8, 2013
FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LRP·March 27, 2009
Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Code EPS04.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GDW·October 23, 2017
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·March 26, 2018
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·March 26, 2018
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
FDA Recall
Open, Classified
·Ethicon Endo-Surgery Inc·Product code GDW·September 11, 2025
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·December 9, 2008
Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GDW·April 2, 2007
Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010
LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GDO·April 12, 2013