FDA Device recall Z-0441-2014
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile by Boston Scientific, citing the 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-05 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Reason
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
Identifiers
| code_info | UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.