The Recall Desk

Manufacturer

Ethicon Endo-Surgery Inc

54 recalls in our database name Ethicon Endo-Surgery Inc as the manufacturing or recalling firm.

What the numbers show

Total
54
Critical
4
Severe
15
Most recent
2025-10-22

Of the 54 recalls from Ethicon Endo-Surgery Inc we have scored against our rubric, 4 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (28%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 54

  • HighFDA (Devices)·Z-1272-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers (Model ECS25A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2019·2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2019·2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2048-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Defect

    Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1886-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Insufficient Lubrication

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1888-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2018·2018-02-28

    Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2174-2017·2017-06-07

    Ethicon Endopath ETS-FLEX Endoscopic Linear Cutter Recalled for Gear Failure Risk

    Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter due to a risk of pinion gear failure under extreme use cases.

    Product
    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0296-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters

    Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.

    Product
    Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0295-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure

    Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.

    Product
    Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0278-2016·2015-11-25

    Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect

    Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.

    Product
    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2374-2015·2015-09-02

    Ethicon Recalls SEDASYS Sedation Systems Due to Plastic Degradation

    Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2015·2015-05-27

    Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect

    Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.

    Product
    ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2014·2014-09-17

    Ethicon Recalls PROXIMATE Skin Staplers Due to Unformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling PROXIMATE skin staplers because a non-conforming component may cause the device to fire an unformed staple.

    Product
    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2014·2013-11-13

    Ethicon Endo-Surgery Recalls Adjustable Gastric Bands Due to Locking Failure

    Ethicon Endo-Surgery Inc is recalling adjustable gastric bands because they failed to meet force-to-lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1777-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.

    Product
    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The ins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2013·2013-07-31

    Ethicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise

    Ethicon Endo-Surgery Inc is recalling 327,648 Endopath Electrosurgery Probe Plus II instruments because a tear in the Tyvek packaging may affect the sterility of the devices.

    Product
    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 flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.

    Product
    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 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 tro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers because potential clip formation and feeding issues may cause vessel damage or insufficient occlusion.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ethicon Endo-Surgery

Country
United States
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q5403439), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.