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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Peter Lazic Gmbh: D-Clip Appliers Recalled for Failure to Release Surgical Clips

Agency Publication Date: March 11, 2024
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Summary

Peter Lazic Gmbh is recalling 99 units of its D-Clip Standard/Mini Appliers because the devices can fail to release the clip during surgery. There has been at least one customer complaint where the applier remained attached to the clip while inside a patient. This recall includes the 190mm, 210mm, and 230mm bayonet models with rigid jaws. Consumers and healthcare providers should identify affected units by model number and contact the manufacturer for next steps.

Risk

The applier may fail to release the clip during a surgical procedure, causing the tool to remain attached to the implanted clip. This malfunction can interfere with the surgical process and may lead to complications or delays during delicate procedures.

What You Should Do

  1. Identify if you have any of the affected D-Clip Standard/Mini Appliers by checking the model numbers on the device or packaging: 35.410 (190mm), 35.411 (210mm), or 35.412 (230mm).
  2. Verify the UDI/DI codes for your units: 04250603739593 (Model 35.410), 04250603739609 (Model 35.411), or 04250603739616 (Model 35.412). This recall applies to all lot numbers for these models.
  3. Immediately contact your healthcare provider or the manufacturer, Peter Lazic Gmbh, for further instructions regarding the use of these devices and potential remedies.
  4. For additional information or questions, you can contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action
Model / REF:
35.410
UPC Codes:
04250603739593
Lot Numbers:
All Lot numbers
Product: D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action
Model / REF:
35.411
UPC Codes:
04250603739609
Lot Numbers:
All Lot numbers
Product: D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action
Model / REF:
35.412
UPC Codes:
04250603739616
Lot Numbers:
All Lot numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93938
Status: Active
Manufacturer: Peter Lazic Gmbh
Sold By: Specialty medical distributors
Manufactured In: Germany
Units Affected: 3 products (26 units; 63 units; 10 units)
Distributed To: Maine

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.