Echelon Flex
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of…
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload.
16manufacturers in China registered for this device type
7catalogue numbers in this listing
44510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
| Lucky Star Lrradiation Science Co., Ltd. Shanghai | Shanghai | Shanghai | Contract manufacturer | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | Shanghai | Specification developer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Staple, Implantable
Record
| Listed by | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2015-08-24 |
| Record revised | 2026-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 10 to 80 % RH; Storage environment temperature -22 to 60 °C |
| Packaging | Box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSEE60A | In distribution | |
| PSEE45A | In distribution | |
| PVE35A | In distribution | |
| PLEE45A | In distribution | |
| PLEE60A | In distribution | |
| PCEE60A | In distribution | |
| PCEE45A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo GIA | Covidien LP | 51 |
| Aeon | Lexington Medical, Inc. | 48 |
| Proximate | Ethicon Endo-Surgery, Inc. | 42 |
| Tri-Staple 2.0 | Covidien LP | 42 |
| EEA | Covidien LP | 37 |
| Echelon Endopath | Ethicon Endo-Surgery, Inc. | 33 |
| Reloading Unit for Endo Linear Cutter Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 28 |
| GIA | Covidien LP | 24 |
| easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | Ezisurg Medical Co., Ltd. | 23 |
| Circular Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 23 |
| Endopath | Ethicon Endo-Surgery, Inc. | 22 |
| Signia | Covidien LP | 19 |
Showing 12 of 105. All products under Staple, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260196 | 2026-05-11 |
| K252739 | 2025-12-17 |
| K250835 | 2025-05-14 |
| K243276 | 2025-02-25 |
| K241630 | 2024-10-28 |
| K223760 | 2023-03-15 |
| K202665 | 2020-10-15 |
| K201280 | 2020-07-27 |
| K200420 | 2020-06-29 |
| K183435 | 2019-02-06 |
| K181653 | 2018-09-18 |
| K163523 | 2017-04-18 |
| K163454 | 2017-01-05 |
| K160521 | 2016-03-22 |
| K150026 | 2015-05-18 |
| K141952 | 2014-11-24 |
| K140560 | 2014-04-22 |
| K131663 | 2013-10-18 |
| K130653 | 2013-03-29 |
| K121600 | 2012-07-16 |
| K112056 | 2011-12-19 |
| K111195 | 2011-08-03 |
| K111111 | 2011-06-08 |
| K103672 | 2011-04-08 |
| K110385 | 2011-03-25 |
| K110049 | 2011-02-10 |
| K102632 | 2010-10-07 |
| K092577 | 2009-09-15 |
| K091322 | 2009-06-01 |
| K081146 | 2008-06-26 |
| K080839 | 2008-05-21 |
| K070887 | 2007-05-25 |
| K062869 | 2007-02-26 |
| K061156 | 2006-07-03 |
| K053631 | 2006-01-30 |
| K051301 | 2005-08-30 |
| K051002 | 2005-05-17 |
| K040038 | 2004-02-04 |
| K030925 | 2003-05-15 |
| K030411 | 2003-03-20 |
| K020779 | 2002-06-05 |
| K013749 | 2002-02-11 |
| K991030 | 1999-05-17 |
| K983536 | 1998-12-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon Endo-Surgery, Inc. | UDI-DI | 2021-06-03 | Class II | Packaging change control | Mislabeled: Labeled on the package as 60mm contains 45mm devices | 763 eaches | 2022-09-14 |
Recalls
18 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-11 | Class II | Under Investigation by firm | The devices were shipped unsterilized. | 3 units | |
| 2025-04-22 | Class I | Device Design | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional ste | 678,526 | |
| 2023-12-11 | Class II | Under Investigation by firm | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, pro | 22,616 (US), 4,476 (OUS) | |
| 2019-10-03 | Class I | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potenti | 255 units | 2021-06-03 |
| 2019-10-03 | Class I | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potenti | 2112 units | 2021-06-03 |
| 2019-10-03 | Class I | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potenti | 849 units | 2021-06-03 |
| 2019-10-03 | Class I | Nonconforming Material/Component | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potenti | 5040 units | 2021-06-03 |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2019-04-11 | Class I | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 434,614 total | |
| 2018-12-07 | Class II | Process control | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired | 15,264 units | 2020-04-29 |
| 2018-12-07 | Class II | Process control | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired | 480 units | 2020-04-29 |
| 2017-10-23 | Class II | Under Investigation by firm | There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples. | 148.913 | 2019-07-18 |
| 2017-03-31 | Class II | Process control | There is a risk that the pinion gear in the device could fail under extreme use cases. | 792 units | 2018-05-03 |
| 2016-07-15 | Class II | Device Design | 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 patien | 105 | 2017-02-28 |
| 2016-07-15 | Class II | Device Design | 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 patien | 213 | 2017-02-28 |
| 2015-02-26 | Class II | Software in the Use Environment | During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line. | 6,744 devices | 2015-11-17 |
| 2013-05-13 | Class II | Device Design | 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. | 57,540 Units | 2014-02-11 |
| 2012-08-03 | Class I | Process change control | Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to diffic | 157,881 devices | 2013-07-12 |
| 2012-03-02 | Not classified | Vendor change control | There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing | 3120 | 2013-03-22 |
| 2011-07-29 | Not classified | Packaging | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the ster | 27,582 instruments | 2013-02-15 |
| 2009-01-13 | Not classified | Other | The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, th | 4,113 UNITS | 2012-05-10 |
| 2007-04-02 | Not classified | Other | The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surg | 23,966 units | 2009-12-09 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 1249 devices. | 2008-10-29 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 65 devices. | 2008-10-29 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 3179 devices. | 2008-10-29 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 1456 devices. | 2008-10-29 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 5687 devices. | 2008-10-29 |
| 2004-11-21 | Not classified | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. | 199 devices. | 2008-10-29 |
| 2003-11-25 | Not classified | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. | 16,962 | 2012-05-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.