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
- RF Cutting Forceps
- Model numbers
- Model: PK-CF0533, UDI: 00821925035867, Lot Numbers: All unexpired
- Sizes
- 5mm 33cm
- 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 PK-CF0533 Cutting Forceps are surgical instruments used for RF cutting and coagulation in endoscopic or open procedures.
Why This Is Dangerous
A welding defect may cause the jaw to fracture during clinical use, risking tissue injury and procedural complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The defect could lead to jaw breakage during surgery, potentially delaying procedures and increasing the risk to patients.
Practical Guidance
How to identify if yours is affected
- 1) Confirm model PK-CF0533.
- 3) Verify that the lot is unexpired.
- 4) If affected, stop using and contact Olympus for remediation.
Where to find product info
Model PK-CF0533 and UDI 00821925035867 appear on device labels and packaging.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- File a report with the FDA if concerns persist.
- Consider legal consultation if remediation is slow or the device caused harm.
How to prevent similar issues
- Verify UDI and model numbers before purchasing surgical devices.
- Request recall status from suppliers and verify replacement welding validation.
- Buy from manufacturers with transparent recall and validation processes.
- Maintain a record of all device identifications and recall communications.
Documentation advice
Keep copies of recall notices, device labels, serial numbers, UDI codes, photographs, and all correspondence with Olympus and healthcare providers.
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Product Details
Model PK-CF0533; UDI 00821925035867; Lot Numbers: All unexpired; Quantity: 444 units; Distribution: Worldwide (US, Canada, EU, Australia, and other regions)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 444 units recalled worldwide
- All unexpired lots affected
- Jaw breakage risk during surgery
- Stop use immediately; follow recall instructions
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Safety Guide
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