Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21
Brand
Ethicon Endo-Surgery
Lot Codes / Batch Numbers
V4206M, V42863, V42Y5T, V4351F.
Products Sold
V4206M, V42863, V42Y5T, V4351F.
Ethicon Endo-Surgery is recalling FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21 due to Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
Recommended Action
Per FDA guidance
The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026