FDAOctober 17, 2025device
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatat...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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). All other components in the kits were correctly included and packaged in the kit.
What to do
FDA enforcement status: Ongoing
Brands named
olympus
UPCs
00821925033016
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21122026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21112026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.2026-03-25
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