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
- Cutting Forceps
- Model numbers
- Model: 920000PK, UDI: 00821925038080, 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 8, 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 designed to pass through a 5mm cannula and are used with an electrosurgical generator for coagulation under visualization.
Why This Is Dangerous
The supplier welding validation issue can lead to jaw fracture under clinical use, creating a risk of instrument failure and potential injury.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must halt use of the affected devices and coordinate with Olympus for replacement or refund while ensuring patient safety.
Practical Guidance
How to identify if yours is affected
- Verify model 920000PK is in your inventory.
- Check the device label for UDI 00821925038080.
- Confirm lot numbers: All unexpired lots are implicated.
- Compare to the recall notice from Olympus for next steps.
Where to find product info
UDI printed on packaging and device label; Model 920000PK identifier on instrument and documentation.
What timeline to expect
4-6 weeks for refund or replacement processing.
If the manufacturer is unresponsive
- Document all communications with the supplier.
- Escalate to hospital procurement or risk management.
- Consider contacting the regulatory authority for guidance on unresponsive vendors.
How to prevent similar issues
- Verify welding validation and supplier QA before procurement.
- Purchase from authorized distributors.
- Keep an up-to-date inventory of high-risk surgical instruments and their identifiers.
Documentation advice
Retain all recall notices, purchase records, serials/UDI, and correspondence with the manufacturer for potential claims.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: 920000PK. Distribution: Worldwide (US nationwide and additional countries). Sold: All unexpired lots. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot numbers: All unexpired
- Active recall as of 2026-02-25
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.