FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.
- Recall number
- Z-1068-2011
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.
- Status
- Terminated
- Initiated
- 2009-03-27
- Posted
- 2011-02-15
- Terminated
- 2013-02-15
- Reason
- The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.
- Root cause
- Other
- Action
- Ethicon Endo-Surgery issued "Urgent Expanded Device Recall Event 1981" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. They are to complete and fax back the Business Reply Form, Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle, Replacement product should be received within 30-60 days after return, Customers can contact Stericycle concerning this recall at 1-888-365-4680, reference Event 1981.
- Quantity
- 29,403 units
- Distribution
- Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.
- Lot, serial or model codes
- The recalled Lot Numbers are: E4MJ47, E4MF6W, E4MK84, E4MM23, E4MM64, E4MP4A, E4MR15, E4MT07, E4MT4Y, F4MU2R, F4MY91, E4MG53, E4MG5K, E4MG5L, E4MN39, E4MG89, E4MG9M, E4MH2L, E4ML6J, E4MG77, E4MG8A, E4MH18, E4MJ3K, F4MX8C, and F4N799.
- 510(k) numbers
- ["K020779","K070887"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28