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
- Surgical Cutting Forceps
- Model numbers
- Model: 3005PK, UDI: 00821925036000, 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
PKS Cutting Forceps are surgical instruments passed through a 5mm cannula and used with electrosurgical energy under visualization. They are designed to be used with the PKS electrical generator.
Why This Is Dangerous
Defective welds can cause the jaw to break during clinical use, posing a risk of injury to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Clinicians may need to halt procedures using these forceps; facilities may face workflow disruptions and potential patient safety concerns.
Practical Guidance
How to identify if yours is affected
- Check model number 3005PK
- Confirm lot numbers are among unexpired lots
Where to find product info
Identify on device packaging, label, and accompanying documentation.
What timeline to expect
Remedy details, including refunds or replacements, will be communicated by Olympus.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement
- File a complaint with the vendor or relevant regulatory body
How to prevent similar issues
- Verify welding validation during supplier audits
- Source from manufacturers with validated welding processes
- Maintain an updated recall log for surgical instruments
Documentation advice
Keep the recall letter, model number, UDI, lot numbers, and correspondence with Olympus for records.
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Product Details
Model: 3005PK\nUDI: 00821925036000\nLot Numbers: All unexpired\nQuantity: 93 units\nSold worldwide: US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan\nRecall date: 2026-02-25\nManufacturer: Olympus Corporation of the Americas\nRemedy: Stop using the device and follow recall instructions. Contact Olympus or your healthcare provider for instructions.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model 3005PK, UDI 00821925036000
- All unexpired lots affected
- Worldwide distribution includes US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan
- No injuries or incidents reported
- Stop using immediately; follow recall instructions
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Safety Guide
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