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.

1–25 of 54

  • HighFDA (Devices)·Z-0147-2026·2025-10-22

    Linear cutter reloads recalled after devices were shipped unsterilized

    Ethicon Endo-Surgery is recalling three ECHELON LINEAR Cutter Reload 80 mm Blue units because the devices were shipped unsterilized.

    Product
    ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1746-2025·2025-05-28

    Endopath Echelon Vascular White Reload surgical stapler device lockout

    Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.

    Product
    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2024·2024-02-07

    Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line

    An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.

    Product
    ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2021·2021-09-01

    HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk

    Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.

    Product
    HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2021·2021-09-01

    Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk

    Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.

    Product
    HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2021·2021-08-25

    Surgical stapler mislabeled with incorrect device size

    Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.

    Product
    ECHELON FLEX Powered Plus Stapler-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. Product Code: PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0656-2020·2019-12-18

    Ligamax 5 mm Endoscopic Clip Applier Recalled for Sterility Breach Risk

    Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.

    Product
    Ligamax 5 mm Endoscopic Multiple Clip Applier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0203-2020·2019-11-06

    Ethicon Echelon Flex Powered Plus Stapler Recalled for Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0202-2020·2019-11-06

    Ethicon Echelon Flex Powered Plus Endopath 60mm Stapler Recall

    Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0201-2020·2019-11-06

    Ethicon Recalls ECHELON FLEX Staplers Due to Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0200-2020·2019-11-06

    Ethicon Echelon Flex Endopath Stapler Recall for Out-of-Spec Anvil

    Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1889-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2019·2019-05-22

    Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A 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 to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1273-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A 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
  • SevereFDA (Devices)·Z-1268-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A 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 to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A 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 to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1271-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

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

    Product
    Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A 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
  • SevereFDA (Devices)·Z-1267-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling Curved Intraluminal Staplers, Model CDH21A, because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A 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 to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1270-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A 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 to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A 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 to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1277-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A 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 to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling 434,614 Curved Intraluminal Staplers (Model CDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A 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 to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2019·2019-05-22

    Ethicon Endo-Surgery Recalls 33 mm Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery Inc is recalling 434,614 Model ECS33A staplers worldwide because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A 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

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.