Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Reported: June 22, 2022 Initiated: April 20, 2022 #Z-1263-2022
Product Description
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Reason for Recall
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 2 units
- Distribution
- CA FL MA MD MI NJ OH PR WI
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6. Recalled by Olympus Corporation of the Americas. Units affected: 2 units.
Why was this product recalled? ▼
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2022. Severity: Moderate. Recall number: Z-1263-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11