Quick Facts at a Glance
- Recall Date
- February 25, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- PKS Cutting Forceps
- Model numbers
- Model: 920005PK, UDI: 00821925036178, Lot Numbers: All unexpired
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 25, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
About This Product
The PKS Cutting Forceps are surgical instruments used with a 5mm cannula and electrosurgical energy under visualization. They are intended to be used with the PKS generator in minimally invasive procedures.
Why This Is Dangerous
The welding validation deficiency can lead to jaw fracture during use, potentially leaving fragments in a patient and compromising the procedure.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Affecting 326 units distributed worldwide, the recall poses a risk to patient safety during surgical procedures and requires immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Verify model number on the instrument handle or packaging is 920005PK.
- Check UDI on packaging: 00821925036178.
- Ensure lot numbers are unexpired; all unexpired lots are included in the recall.
Where to find product info
Look at device packaging, instrument tray labels, and the recall notice from Olympus and the FDA page Z-1644-2026.
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate to the hospital’s risk management department.
- File a recall complaint with the FDA if the manufacturer is nonresponsive.
How to prevent similar issues
- Verify device compatibility and welding quality before use.
- Ensure recall alerts are subscribed for medical device notices.
- Follow official supplier channels for future instrument recalls.
Documentation advice
Save the recall notice, model and UDI details, correspondence with Olympus, and any related shipping receipts.
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Product Details
Model: 920005PK UDI: 00821925036178 Lot Numbers: All unexpired Quantity: 326 units Distribution: Worldwide — US nationwide, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan Brand: Olympus Corporation of the Americas Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution (US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan)
- Jaw fracture risk due to welding defects
- Stop use immediately; follow manufacturer recall instructions
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Safety Guide
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