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Weck

Country not established

Devices
2
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Weck makes

Weck manufactures surgical clips and applicators designed for vascular and soft tissue ligation, including the HEM-O-LOK XL clip and its automated applicator. These products are intended for use in procedures requiring secure tissue occlusion, such as vascular surgery or trauma management.

The company’s portfolio is regulated under FDA Class II devices, with products authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by Weck, the earliest on 2001-01-25 and the most recent on 2004-08-18. By recorded status: 13 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 13 recalls.

  • 2004

    • 18 Aug 2004 Z-0031-05 Unclassified (pre-2012) Terminated The jaws may break during clip loading or clip application. Distribution: Nationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.
    • 23 Jan 2004 Z-0547-04 Unclassified (pre-2012) Terminated Malformation of the Hem-o-lok SMX clip. Distribution: Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France Submission number: K982941

  • 2003

    • 24 Oct 2003 Z-1385-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1386-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1387-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1388-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1389-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1390-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1391-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
    • 24 Oct 2003 Z-1392-04 Unclassified (pre-2012) Terminated Hole in the sterile unit blister pack that could compromise sterility. Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
Show all 13 recalls

  • 2003

    • 21 May 2003 Z-0418-05 Unclassified (pre-2012) Terminated Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment. Distribution: Nationwide

  • 2001

    • 31 Oct 2001 Z-0393-05 Unclassified (pre-2012) Terminated The flush port on some appliers was occluded with an epoxy resin during manufacturing. Distribution: AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
    • 25 Jan 2001 Z-0340-05 Unclassified (pre-2012) Terminated An incorrect electrosurgical cord was included in some of the packages. Distribution: Nationwide, Singapore

Frequently asked questions

How many devices does Weck have in the registry?

The registry currently lists 2 devices for Weck. Devices recorded under merged duplicate company entries are counted once.

Which registries list Weck's devices?

Among its 2 most recently registered devices, Weck has devices listed in FDA 510(k) (2 devices).

What risk classes do Weck's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Weck's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Weck?

FDA recall records list 13 recalls initiated by Weck, the most recent initiated on 18 Aug 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Weck in the registry?

The most recently registered devices listed for Weck include HEM-O-LOK XL CLIP and WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER.

Generated automatically from registry data and not verified by a human reviewer.