FEI 1480288

Hollister Incorporated

2000 HOLLISTER DR., LIBERTYVILLE, IL, US

MDR events744All time

Recalls5All time

Registered products31

Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

31 product codes

Recent MDR events

744 on file

Recalls

5 on file

Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗
Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗
Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗
Open, ClassifiedFeb 19, 2025
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
View FDA record ↗
TerminatedUnknown
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.
View FDA record ↗

Compliance history

Matched by FEI 1480288.

FDA inspections

0 on file

No inspections on file for this FEI number.

Inspection citations

0 on file

No citations on file for this FEI number.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

1 on file

Top refusal reasons

Compare to industry ↗

Division of Southeast Imports (DSEI)Jul 16, 2025
78EZR \ CEMENT, STOMAL APPLIANCE, OSTOMY