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Hollister Incorporated

United States·US-MF-000027818

Last updated September 17, 2026

About

Hollister Incorporated manufactures quality medical products for ostomy, continence, wound and critical care markets. Learn about our products and services.

From the manufacturer's own website. Source

Information

Country: United States
Address: 2000, Hollister Drive, Libertyville, Illinois, United States
Website: www.hollister.com
LinkedIn: linkedin.com/company/hollister-incorporated
Facebook: facebook.com/HollisterIncorporated
Email: [email protected]
Phone: +18476801000
PRRC Contact: —
EUDAMED SRN: US-MF-000027818
FDA FEI Number: 1119193
DUNS Number: —

Catalogue (1504)

Page 1 of 31

Device	Model / Reference	Registries	Class	Status
Coude Sleeved IC; Coude Plus Sleeved IC	K253295	FDA 510(k)	Class II	Active
New Image	16107	FDA UDI	Class I	Active
New Image	15804	FDA UDI	Class I	Active
Restore	529975	FDA UDI	U	Active
Premier	85211	FDA UDI	Class I	Active
New Image	14308	FDA UDI	Class I	Active
Hollister	9775	FDA UDI	Class I	Active
Securi-T	7325134	FDA UDI	Class I	Unknown
New Image	14804	FDA UDI	Class I	Active
InView Standard	97532-100	FDA UDI	Class I	Active
InView Extra	97629-100	FDA UDI	Class I	Active
Premier	88735	FDA UDI	Class I	Active
Premier	8131	FDA UDI	Class I	Active
New Image	153103	FDA UDI	Class I	Active
New Image	19804	FDA UDI	Class I	Active
Karaya 5	3275	FDA UDI	Class I	Unknown
New Image	18404	FDA UDI	Class I	Active
Advance Plus	97144	FDA UDI	Class II	Active
Premier	8988	FDA UDI	Class I	Active
Onli	82104-30	FDA UDI	Class II	Active
Premier	8632	FDA UDI	Class I	Active
New Image	15602	FDA UDI	Class I	Active
Premier	8496	FDA UDI	Class I	Active
Premier	88725	FDA UDI	Class I	Active
New Image	18364	FDA UDI	Class I	Active
Securi-T	7825134	FDA UDI	Class I	Unknown
Premier	84294	FDA UDI	Class I	Active
Premier	8438	FDA UDI	Class I	Active
Premier	8992	FDA UDI	Class I	Active
Premier	82300	FDA UDI	Class I	Active
New Image	18294	FDA UDI	Class I	Active
Premier	8283	FDA UDI	Class I	Active
New Image	11704	FDA UDI	Class I	Active
Premier	84494	FDA UDI	Class I	Active
Premier	8439111	FDA UDI	Class I	Active
New Image	14103	FDA UDI	Class I	Active
New Image	18004	FDA UDI	Class I	Active
Premier	82610	FDA UDI	Class I	Active
Apogee Plus	B14CB	FDA UDI	Class II	Active
VaPro Plus Pocket Kit	79109K	FDA UDI	Class II	Active
Restore	519923	FDA UDI	Class I	Active
AnchorFast	9799	FDA UDI	Class I	Active
Premier	8633	FDA UDI	Class I	Active
Apogee HC	91226	FDA UDI	Class II	Active
Premier	8538	FDA UDI	Class I	Active
Securi-T	7829214	FDA UDI	Class I	Unknown
Premier	8552	FDA UDI	Class I	Active
Premier	8480	FDA UDI	Class I	Active
InView Extra	97641-100	FDA UDI	Class I	Active
New Image	13904	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Hollister ULC IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 23, 2024	Z-1178-2025	—	open, classified	Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Dec 23, 2024	Z-1180-2025	—	open, classified	Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Dec 23, 2024	Z-1179-2025	—	open, classified	Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Dec 23, 2024	Z-1181-2025	—	open, classified	Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Feb 11, 2021	Z-1311-2021	—	terminated	The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.