Recall database

Catheter, Nephrostomy recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0572-2026

Olympus Corporation Of The Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Nam…

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815).…

Nephrostomy Catheter
Process control

Olympus Corporation of…PANov 26, 2025

Class IIOngoingZ-2535-2025

Boston Scientific Corporation recalls Boston Scientific NephroMax Kit

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…

Nephrostomy Catheter
Under Investigation by firm

Boston Scientific Corp…MNSep 17, 2025