Z-2164-2008

FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B...

Name: Z-2164-2008 FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B...
Creator: Ethicon Endo-Surgery Inc
Published: 2008-04-24
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2008-04-24 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general... on 2008-04-24. The reason FDA records is "The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2164-2008
Status: Terminated
Initiated: 2008-04-24
Posted: 2008-08-25
Terminated: 2012-04-03
Recalling firm: Ethicon Endo-Surgery Inc
Product: FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Product code: FZT Cutter, Surgical
Reason for recall: The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Root cause tag: manufacturing process
FDA 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 in commerce: 863 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.
Product codes and lots: Batch #: D4GR6F, D4GR6P, D4GT7G, D4H14H; Product Code: FD064, Batch # D4G520; Product Code: FDB15, Batch # D4GD04; Product Code: TGL45XL, Batch # D4J493; Product Code: XBB02B, Batch # D4GK74, D4GU1T, D4HL3X, D4HL7C, D4HM4P, D4HM9D, D4JE0R; Product Code: XBB58S, Batch # D4G94G, D4GK69, D4GP93, D4GW31, D4HG6V, D4J204; Product Code: XBB59S, Batch # D4GA1K, D4GC1G, D4GD9U, D4GD7C, D4GX8R, D4HD17, D4HD6X, D4HE54, D4HM6G; Product Code: XLB01B, Batch # D4GD0R, D4GF8J, D4H593, D4HR87; Product Code: XLB50S, Batch # D4GK4X, D4GP94, D4GT3K, D4HF0V, D4J47E, D4JE8P; Product Code: XPD51S, Batch # D4GT7T, D4HF7M , D4J32T

Product code FZT

K020779Class IIProximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. / cleared 2002-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)