Data / Medical devices / Ireland / Hollister ULC

Hollister ULC: FDA-registered device maker in REHINS BALLINA Mayo, Ireland, 10 510(k) clearances

Name: Hollister ULC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hollister ULC is registered with the FDA (registration 9616668) in REHINS BALLINA Mayo, Ireland. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 18, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616668
FEI number: 3005028195
Address: Foxford RD., REHINS BALLINA Mayo, Ireland, F26 F3X5
Owner or operator: Hollister Inc. (1480288)
Roles: Manufacturer
First device listed: July 21, 1992
Registered through: 2026
Brand names listed: Adapt, Center Point Lock, Compact, Conform 2, Dansac, DuoSoft, Fecal Collectors, First Choice and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Urine Collecting, Ureterostomy	EXG	1	Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Collector, Ostomy	EXB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 18, 2026	K253295	Coude Sleeved IC; Coude Plus Sleeved IC	EZD	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
May 3, 2024	K233524	Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)	EZD	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
September 13, 2022	K213575	Female IC (Not Finalized)	EZD	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
January 27, 2022	K211436	Intermittent Catheter (Not Finalized)	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
December 13, 2019	K193148	VaPro Plus Pocket, VaPro Plus	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
December 18, 2018	K183253	ValPro 2 Plus, VaPro 2 Plus Pocket	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
June 22, 2018	K180824	VaPro 2 Intermittent Catheter	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
September 9, 2015	K152268	VAPRO PLUS POCKET Intermittent Catheter	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
January 9, 2015	K143594	VaPro Pocket	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov
August 22, 2014	K141642	VAPRO INTERMITTENT CATHETER	GBM	Substantially Equivalent	Hollister Incorporated	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 14, 2026	99497	Class II	Ongoing	Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF	Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.	accessdata.fda.gov

Compare with other makers

Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.