Reported Aug 23, 2023 · Ongoing
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models
64 of 64 products
| # | Product as published |
|---|---|
| 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 |
- Amount recalled
- 62704 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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