ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible… — Class II medical device recall Z-1530-2013
Terminated recall by Ethicon Endo-Surgery Inc, reported 2013-06-19, distributed nationwide. Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to
| Recall number | Z-1530-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-06-11 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BR, CA, CL, EG, IL, IN, JO, KR, KW, LB, MX, MY, NZ, QA, RU, SA, SG, TR, TW |
| Quantity | 57,540 units |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.