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FDA Medical Device Recalls (openFDA)

Conmed Endoscopic Technologies, Inc.: Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040

Recall number
Z-0729-2007
Recalling firm
Conmed Endoscopic Technologies, Inc.
Product
Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
Status
Terminated
Initiated
2007-03-14
Posted
2007-04-11
Terminated
2007-05-15
Reason
Blue safety clip incorrectly placed on the stent may prevent deployment
Root cause
Other
Action
ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.
Quantity
11 UNITS
Distribution
Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
Lot, serial or model codes
Lot Numbers: ANQJO636, ANQJO637
510(k) numbers
["K031186"]
PMA numbers
not on file
Product code
FGE
Firm FEI
1000159712
Firm city
Billerica
Firm state
MA
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

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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

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