FDA Device Recalls

Recalls / Firms / Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc

109 FDA device recalls on record.

DateClassProductReason
2025-09-11ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of an
2025-04-22Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR
2023-12-11ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, End
2021-07-20HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding contro
2021-07-20HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding contr
2021-06-03ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomose
2019-11-07Ligamax 5 mm Endoscopic Multiple Clip Applier
2019-10-03ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
2019-10-03ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
2019-10-03ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
2019-10-03ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
2019-05-15Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
2019-05-15Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
2019-05-15Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
2019-04-11Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal St
2019-04-11Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal
2019-04-11Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intra
2019-04-11Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intra
2019-04-11Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intra
2019-04-11Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intra
2019-04-11Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal
2019-04-11Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal St
2019-04-11Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal
2019-04-11Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal St
2019-04-11Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal
2019-04-11Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal St
2018-12-07PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoi
2018-12-07PROXIMATE PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE PPH Hemorrhoida
2018-05-03HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code
2018-05-03HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code
2018-03-265mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft
2018-03-265mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft
2018-03-265mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft
2018-03-265mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft
2018-03-265mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft
2017-10-23Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the aliment
2017-03-31Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
2016-07-15Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Artic
2016-07-15Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic
2015-09-23HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo
2015-05-13SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological mon
2015-02-26ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments
2014-08-12PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed
2013-09-30Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
2013-09-30Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
2013-09-30Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
2013-05-13ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The EC
2013-04-12LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP E
2013-04-12LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usag
2013-04-12LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product
2013-04-08Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, rig
2012-11-06Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mec
2012-10-04PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide
2012-08-03Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrho
2012-03-16HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually
2012-03-02The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - St
2012-01-26ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL 5 mm Diam
2012-01-26ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Eth
2012-01-26ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Di
2012-01-26ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENS
2011-07-29ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45
2010-09-27REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code R
2010-09-27SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier Product Code BD3X
2010-09-27REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" troca
2010-09-27REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82
2010-09-27ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW
2010-09-27REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90,
2010-09-27SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Prod
2010-09-27REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZ
2010-09-27REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #: G4RK3F, G4
2010-09-27REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot #: G4RK0M, G
2010-09-27REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJBBBY, ZJC
2010-09-27REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" tro
2010-09-27REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB
2010-09-27REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG
2010-09-27REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube. Product Code R
2010-09-27REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6
2010-09-27Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 0209060
2010-07-09Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
2009-03-27ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; A
2009-03-27FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- B
2009-01-13ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon E
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Code EPS06)
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Cod
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code EPS01)
2008-12-09Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (Product Co
2008-04-24ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecolog
2008-04-24ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, an
2008-04-24ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologic, and th
2008-04-24FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S,
2007-11-06Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surg
2007-04-02Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoi
2006-04-20Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length, hollow tip electrode, Co
2006-04-20Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length, hollow tip electrdode, Product Cod
2006-04-20Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip electrode, Code EPS06.
2006-04-20Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip electrode, Produ
2006-04-20Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01.
2006-04-20Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Product Co
2006-04-20Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip electrode, Code EPS09.
2006-04-20Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.
2006-04-20Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13.
2006-04-20Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04.
2006-04-20Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02.
2006-04-20Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip electrode, C