FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
- Recall number
- Z-2163-2008
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
- Status
- Terminated
- Initiated
- 2008-04-24
- Posted
- 2008-08-25
- Terminated
- 2012-04-03
- Reason
- The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
- Root cause
- Other
- Action
- Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.
- Quantity
- 14,784 pieces
- Distribution
- Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
- Lot, serial or model codes
- Batch #s: D4G80E, D4G85W, D4G903, D4G94L, D4GA32, D4GD36, D4GE66, D4GH0T, D4GJ2K, D4GK3Y, D4GK9L, D4GM52, D4GM7U, D4GN6E, D4GP0J, D4GP4R, D4GP72, D4GR0X, D4GT2T, D4GV6T, D4GV87, D4GW38, D4GW9W, D4H070, D4H18C, D4H22G, D4H44D, D4H46J, D4H48L, D4H49L, D4H51F, D4H60R, D4H70P, D4H72W, D4H77M, D4H86J, D4H903, D4H930, D4HA5E, D4HC0M, D4HC72, D4HE2N, D4HG0T, D4HG35, D4HG6F, D4HG9G, D4HH5V, D4HH9D, D4HJ8K, D4HL4G, D4HM5L, D4HN53, D4HP27, D4HP58, D4HP9X, D4HR68, D4HT58, D4HU52, D4HW1L, D4HW24, D4HW7N, D4HX45, D4HX8P, D4HY1D, D4HY6U, D4HZ5K, D4J03R, D4J08F, D4J13C, D4J187, D4G51J, D4G56F, D4G69L, D4G725
- 510(k) numbers
- ["K020779"]
- PMA numbers
- not on file
- Product code
- FZT
- 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