FDA Device Intelligence
HomeHOLLISTER INCORPORATED › Premier

Premier

HOLLISTER INCORPORATED · Model 84134 · UDI-DI 00610075064458

EXG
0
510(k) clearances
29
Adverse events
1
Recalls
58
Facilities

Description

1-Piece Urostomy Pouch, Soft Convex, CeraPlus

Recalls

DateFirmReason
2026-07-06ConvaTec, IncUrostomy Pouches may leak from cap during use.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.