Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 26, 2016
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
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ethicon Endo-Surgery Inc recalled Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex… - a moderate-severity action.
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex… was recalled by Ethicon Endo-Surgery Inc in October 26, 2016. Reason: Quality control identified a component issue where the pinion gear in the device could fail under extreme use…. Check the official notice for the remedy. Verify recall #Z-0296-2017 with the FDA Devices before acting.
The recall
Ethicon Endo-Surgery Inc issued this moderate-severity FDA Devices recall-Quality control identified a component issue where the pinion gear in the device could fail under extreme use….
- Moderate
- severity level
- 213 units
- affected scope
- Class II
- classification
- October 26, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0296-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0296-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on July 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ethicon Endo-Surgery Inc is listed as the recalling firm, operating out of Blue Ash, OH. Federal records list the affected scope as 213.
The documented reason for this recall is: Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and re… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
213
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0296-2017 |
| Date reported | October 26, 2016 |
| Date initiated | July 15, 2016 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Firm location | Blue Ash, OH |
| Affected scope | 213 |
| Distribution | Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0296-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ethicon Endo-Surgery Inc. Units affected: 213.
Why was this product recalled? ▼
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0296-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0296-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 26, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.