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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

Olympus Single Use Electrosurgical Knives Recalled for Tip Breakage Risk

Agency Publication Date: January 30, 2026
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Summary

Olympus Corporation of the Americas has recalled 3,361 Single Use Electrosurgical Knives (models KD-640L and KD-645L) because the cutting knife can deteriorate, overheat, or burn. These issues can cause the tip of the knife to break off during surgery. The affected devices were distributed nationwide in the United States.

Risk

A broken knife tip during an endoscopic procedure may require additional surgery to retrieve the fragment or could cause internal tissue damage or bleeding. Deterioration of the device during use also poses a risk of thermal injury or burns to the patient's internal tissues.

What You Should Do

  1. Identify your device by checking the product label for Model/Catalog Numbers KD640-L or KD-645L.
  2. Check the lot number on the packaging. Affected lot numbers include 2ZK, 31K, 32K, 33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 41K, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, and 59K.
  3. Stop using the recalled device immediately.
  4. Contact Olympus Corporation of the Americas or your distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus Single Use Electrosurgical Knife KD-640L
Model / REF:
KD640-L
Lot Numbers:
2ZK
31K
32K
33K
34K
35K
36K
37K
38K
39K
3XK
3YK
3ZK
41K
42K
43K
44K
45K
46K
47K
48K
49K
4XK
4YK
4ZK
51K
52K
53K
54K
55K
58K
59K
UDI:
04953170208423

Intended to deliver current for cutting/coagulation/ablation during endoscopic surgery.

Product: Olympus Single Use Electrosurgical Knife KD-645
Model / REF:
KD-645L
Lot Numbers:
2ZK
31K
32K
33K
35K
3XK
3YK
3ZK
42K
43K
44K
45K
46K
47K
48K
49K
4XK
4YK
4ZK
51K
52K
53K
54K
55K
56K
57K
58K
59K
UDI:
04953170407857

Intended to deliver current for cutting/coagulation/ablation during endoscopic surgery.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98007
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 2 products (units; 3361 units)
Distributed To: Nationwide

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.