Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 19, 2013
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can r
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage…
Ethicon Endo-Surgery Inc recalled ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek l… - a moderate-severity action.
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek l… was recalled by Ethicon Endo-Surgery Inc in June 19, 2013. Reason: Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to…. Check the official notice for the remedy. Verify recall #Z-1530-2013 with the FDA Devices before acting.
The recall
Ethicon Endo-Surgery Inc issued this moderate-severity FDA Devices recall-Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to….
- Moderate
- severity level
- 58K units
- affected scope
- Class II
- classification
- June 19, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1530-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1530-2013) was formally reported on June 19, 2013, with the manufacturer initiating the action on May 13, 2013. 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 Cincinnati, OH. Federal records list the affected scope as 57,540 Units.
The documented reason for this recall is: Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puert…. 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
57,540 Units
Related Recalls
6
3 from same agency
Product description
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¿" lock-out feature is designed to prevent a used reload from being refired.
Reason for recall
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1530-2013 |
| Date reported | June 19, 2013 |
| Date initiated | May 13, 2013 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Firm location | Cincinnati, OH |
| Affected scope | 57,540 Units |
| Distribution | Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Colu… |
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-1530-2013) 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? ▼
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¿" lock-out feature is designed to prevent a used reload from being refired.. Recalled by Ethicon Endo-Surgery Inc. Units affected: 57,540 Units.
Why was this product recalled? ▼
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2013. Severity: Moderate. Recall number: Z-1530-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1530-2013) 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 June 19, 2013. 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.