HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopi...
FDA Device Recall #Z-2413-2023 — Class II — June 8, 2023
Recall Summary
| Recall Number | Z-2413-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 8, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Olympus Corporation of the Americas |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 62704 boxes |
Product Description
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S
Reason for Recall
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
# Model UDI(DI) 1) A22201C 14042761036648 2) A22201D 14042761036655 3) A22202C 14042761036662 4) A22203C 14042761036686 5) A22205C 14042761036709 6) A22205D 14042761036716 7) A22206C 14042761036723 8) A22207C 14042761036747 9) A22211C 14042761036761 10) A22221C 14042761029466 11) A22222C 14042761030431 12) A22223C 14042761029770 13) A22231C 14042761036778 14) A22231D 14042761036785 15) A22251C 14042761036815 16) A22253C 14042761036822 17) A22255C 14042761036839 18) A22257C 14042761030448 19) A22258C 14042761036853 20) A22266C 14042761036891 21) A44728C 14042761039090 22) WA22037C 14042761051566 23) WA22038C 14042761051580 24) WA22039C 14042761051603 25) WA22301D 14042761051658 26) WA22301S 14042761082386 27) WA22302D 14042761051665 28) WA22305D 14042761051672 29) WA22305S 14042761082393 30) WA22306D 14042761051689 31) WA22332D 14042761051702 32) WA22351C 14042761051719 33) WA22355C 14042761051719 34) WA22503D 14042761068205 35) WA22507D 14042761068236 36) WA22521C 14042761068243 37) WA22523C 14042761068267 38) WA22537D 14042761073940 39) WA22538C 14042761073964 40) WA22539D 14042761073971 41) WA22540S 14042761083710 42) WA22541S 14042761083727 43) WA22542S 14042761083734 44) WA22544S 14042761083758 45) WA22557C 14042761068342 46) WA22566S 14042761083765 47) WA22602D 14042761075456 48) WA22603D 14042761075463 49) WA22606D 14042761075470 50) WA22607D 14042761075487 51) WA22621C 14042761075494 52) WA22623C 14042761075500 53) WA22632D 14042761075517 54) WA22651C 14042761075524 55) WA22655C 14042761075531 56) WA22657C 14042761075548 57) WA47505S 14042761085035 58) WA47506S 14042761085042 59) WA47507S 14042761085073 60) WA47540S 14042761085103 61) WA47551S 14042761085059 62) WA47555S 14042761085066 63) WA47560S 14042761085080 64) WA47566S 14042761085097 All lot numbers
Other Recalls from Olympus Corporation of the Americas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1641-2026 | Class II | Brand Name: Olympus HALO PKS Cutting Forceps, 5... | Feb 25, 2026 |
| Z-1640-2026 | Class II | Brand Name: Olympus PK Cutting Forceps, 5mm 33c... | Feb 25, 2026 |
| Z-1642-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33... | Feb 25, 2026 |
| Z-1639-2026 | Class II | Brand Name: Olympus Everest Bipolar Cutting For... | Feb 25, 2026 |
| Z-1643-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps w/Cord,... | Feb 25, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.