Echelon Linear CutterRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Echelon Linear Cutter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 166
- Deaths reported
- 2
- Injuries reported
- 37
- Recalls
- 1
We found 5 models of Echelon Linear Cutter by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 166 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2024 and Sep 22, 2026 — classified as 2 deaths, 37 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (41 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Echelon Linear Cutter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 11, 2025Open, Classified
The devices were shipped unsterilized.
Z-0147-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Echelon Linear Cutter problems
Device problems
- Failure to Fire41
- Adverse Event Without Identified Device or Use Problem38
- Failure to Form Staple33
- Appropriate Device Problem Term/Code Not Available23
- Device Markings/Labelling Problem20
- Difficult to Open or Close16
- Material Integrity Problem10
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- Hemorrhage/Blood Loss/Bleeding24
- Failure to Anastomose21
- Unspecified Tissue Injury6
- Abdominal Pain2
- Bacterial Infection2
- Unspecified Infection2
- Adhesion(s)1
Echelon Linear Cutter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Echelon Linear Cutter GLC80Staple, implantable1 recall2 deaths113 reports
- Echelon Linear Cutter GLC100Stapler, surgical38 reports
- Echelon Linear Cutter GLC60Staple, implantable8 reports
- Echelon Linear Cutter GLCR80BStaple, implantable5 reports
- Echelon Linear Cutter GLCR100BStaple, implantable2 reports
Recent Echelon Linear Cutter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857300 ↗MalfunctionSep 17, 2026Unintended Compatibility
It was reported that during an Unknown procedure the GLC Linear cutter broke from the Anvil part. Unable to fire the cartridge.Was there any reported patient or user harm? No. Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802482 ↗InjurySep 16, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
It was reported that during the revision surgery, his counterpart used GLC and the staple line opened up again. They did another revision and hand tied the anastomosis this time. The GLC was used on the revision on (b)(6) and then that staple line opened up so they needed to do another revision, which they hand tied the anastomosis with suture rather than stapling a third time.
Patient problems: Failure to Anastomose
MAUDE report 50793807 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50793750 ↗MalfunctionSep 15, 2026Material Integrity Problem
It was reported that during an Unknown procedure the GLC100 device was activated during the procedure. During the use of the third reload, a component detached from the device, resulting in device malfunction and preventing further use of the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772111 ↗MalfunctionSep 14, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762649 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761710 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756116 ↗MalfunctionSep 2, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563618 ↗MalfunctionAug 18, 2026Failure to Cut; Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302251 ↗MalfunctionAug 18, 2026Structural Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301009 ↗MalfunctionAug 17, 2026Failure to Fire
It was reported that during an Unknown surgery, no staples deployed. Suture was used to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276607 ↗MalfunctionAug 4, 2026Failure to Fire
It was reported that during an Unknown procedure unable to push GLC100 lever up to fire after multiple tries Was surgery delayed due to the reported event? Unknown, Was procedure successfully completed? Unknown, Were fragments generated? Unknown, If yes, were they removed easily without additional intervention? Unknown,Patient Status/ Outcome / consequences No, Was other medical intervention (e.g. X-rays, additional procedures, prescriptions, OTC, revision) required: Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131554 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the product used was a GLC80 with a blue reload. It was used to resect a portion of the small bowel in an emergency procedure. There were no issues during the procedure and recovery for the first 6 days was as expected. However the surgeon emailed to say the patient had a small bowel tumour resection with Barcelona type anastomosis. Proven bleed from anastomosis on CT angiogram- self limiting however. Patient came back into hospital and had to have a blood transfusion. The patient has recovered.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50097822 ↗MalfunctionJul 13, 2026Failure to Fire; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798977 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page