Ethicon Endo-Surgery recalls

• May 28, 2025Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm… Class IFirm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs…
• April 9, 2025Pds¿Plus¿Vio¿30In(75Cm)¿Usp6-0(M0.7)¿D/A¿C-1¿Mp and 3 more products Class IIIdentified curing issues with the silicone during the needles manufacturing process.
• Feb. 7, 2024ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST)… Class IIThere is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient…
• Sept. 1, 2021HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft… and 1 more product Class IIAn internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may…
• Aug. 25, 2021ECHELON FLEX Powered Plus Stapler-intended for transection… Class IIMislabeled: Labeled on the package as 60mm contains 45mm devices
• Dec. 18, 2019Ligamax 5 mm Endoscopic Multiple Clip Applier Class IIA potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of…
• Nov. 6, 2019ECHELON FLEX ENDOPATH 60mm Stapler… and 3 more products Class IThe staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which…
• July 3, 2019Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE… and 2 more products Class IIObserved reported incidence rate for harm associated with intraoperative bleeding
• May 22, 2019Curved Intraluminal Staplers… and 11 more products Class IThe staplers may have an insufficient firing stroke to break the washer and completely form staples.
• Jan. 16, 2019PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01… and 1 more product Class IIHemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the…
• June 6, 2018HARMONIC ACE Shears + Adaptive Tissue Technology… and 1 more product Class IIThe devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
• May 23, 20185mm Endopath Xcel with Optiview Technology… and 4 more products Class IIUse of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in…
• Feb. 28, 2018Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract… Class IIThere is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
• June 7, 2017Endopath ETS-FLEX Endoscopic Articulating Linear Cutter… Class IIThere is a risk that the pinion gear in the device could fail under extreme use cases.
• Oct. 26, 2016Endoscopic Articulating Linear Cutter… and 1 more product Class IIQuality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs…
• Nov. 25, 2015HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm… Class IIComplaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
• Sept. 2, 2015SEDASYS Computer-Assisted Personalized Sedation System… Class IEthicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of…
• May 27, 2015ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip… Class IIDuring an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple…
• Sept. 17, 2014PROXIMATE Skin Stapler… Class IIThe device may have a non-conforming component that may cause the device to fire an unformed staple.
• Nov. 13, 2013Adjustable Gastric Band… and 2 more products Class IIDuring aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
• July 31, 2013LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)… and 2 more products Class IIEthicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip…
• July 31, 2013Endopath Electrosurgery Probe Plus II… Class IIThe firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the…
• June 19, 2013ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid… Class IIEthicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple…
• March 13, 2013PSX PROXIMATE Skin Staple Extractor… Class IIDamage to the packaging may have compromised the sterility of the device.
• Feb. 6, 2013Ethicon Endo-Surgery Inc… Class IIPotential for self activation while the device is in use, which may result in unintended thermal damage.
• Oct. 24, 2012Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular… Class IEthicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and…
• May 25, 2012HPBLUE: HARMONIC Blue Hand Piece… Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece…
• May 18, 2012The ECHELON 60 Endoscopic Linear Cutter… There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this…
• March 21, 2012ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw… and 3 more products Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two…
• Sept. 12, 2011ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters… Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters…
• Feb. 15, 2011ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters… and 1 more product The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due…
• Nov. 15, 2010ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters… The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue…
• Nov. 2, 2010REALIZE Adjustable Gastric Band… and 15 more products The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking…
• Sept. 30, 2010Enseal TRIO Product Code ETRIO335H… The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the…
• Sept. 27, 2010ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U… This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW"…
• Jan. 27, 2009Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook… and 8 more products Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to…
• Aug. 25, 2008ENDOPATHETS-Flex Endoscopic Linear Cutter… and 3 more products The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
• Jan. 29, 2008Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery… Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
• June 28, 2007Proximate PPH… The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and…
• May 31, 2006Endopath Probe Plus II… and 11 more products There is the possibility of a seal void in the Probe Plus packaging which may compromised the sterility of the device.
• April 27, 2005Endopath 5 mm Graspers with Ratchet Handles (product code 5DSG) and 35 more products Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles…
• March 25, 2005ABSOLOK Extra Absorbable Ligating Clip cartridges… and 3 more products The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the…
• Feb. 1, 2005Endopath EZ45 Endoscopic Linear Cutter (EZ45B) and 5 more products The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
• Jan. 27, 2005Mammotome EX Holster A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.
• July 20, 2004LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex… This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or…
• Dec. 17, 2003Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear… and 14 more products A defective articulation band may result in improper staple formation with possible hematosis.
• July 8, 2003Proximate Linear Cutter with Safety Lock-Out… and 1 more product The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.

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