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FDA Medical Device Recalls (openFDA)

Weck: Hem-o-lok Endo5 Ligation Applier

Recall number
Z-0031-05
Recalling firm
Weck
Product
Hem-o-lok Endo5 Ligation Applier
Status
Terminated
Initiated
2004-08-18
Posted
2004-10-22
Terminated
2005-01-31
Reason
The jaws may break during clip loading or clip application.
Root cause
Other
Action
Consignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).
Quantity
119 units
Distribution
Nationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.
Lot, serial or model codes
Catalog number 544965, Lot 943704, 943705, 954592
510(k) numbers
not on file
PMA numbers
not on file
Product code
HBT
Firm FEI
3005747797
Firm city
Research Triangle Park
Firm state
NC
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

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