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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a severity score of at least 4. The hazard involves potential death and serious injury from compromised staple lines, fitting the criteria for Severe.
Plain-English summary
Ethicon Endo-Surgery Inc has initiated a recall of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler with a 280mm shaft (Product Code PCEE60A). The company is recalling 255 units associated with lot numbers T93Z9Y and T9411A. These devices were distributed worldwide, including in the United States, Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
The recall addresses a manufacturing defect where the staplers may contain an out-of-specification anvil component within the device's jaw. This defect can lead to the formation of malformed staples during surgical procedures.
Malformed staples can compromise the integrity of the staple line created by the device. If the staple line is compromised, patients face potential risks including prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, the need for additional surgical intervention, or death.
The recalled product
- Product
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 255
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: T93Z9Y
- T9411A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Ethicon Endo-Surgery Inc
See all →- HighLinear cutter reloads recalled after devices were shipped unsterilized
FDA (Devices) · 2025-10-22
- CriticalEndopath Echelon Vascular White Reload surgical stapler device lockout
FDA (Devices) · 2025-05-28
- HighEndoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
FDA (Devices) · 2024-02-07
- HighSurgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
FDA (Devices) · 2021-09-01
- HighHARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
FDA (Devices) · 2021-09-01
Same hazard · malformed staples
See all →- SevereEthicon Echelon Flex Powered Plus Endopath 60mm Stapler Recall
FDA (Devices) · 2019-11-06
- HighEthicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk
FDA (Devices) · 2018-02-28