Facility

Hollister Medical India Private Limited

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008191244
Establishment type	Manufacture Medical Device
Location	Plot No. 27, Sector 5 Bawal, Rewari Haryana, IN 12350
Registration status	Active · expires 2026
Parent company	Hollister Inc. (owner-operator 1480288)
Brand names	Leg Bag Straps; Deluxe Urinary leg Bag Straps; Urinary Leg Bag; Latex-Free Extension Tubing; Extension Tubing with Connector; Hollister; Urinary Leg Bag Holsters

Activity by year

Recalls (2)

Devices registered here (1)

Bag, Urine Collection, Leg, For External Use, Non-Sterile
Product code NNW (opens in a new tab) · Class I · Gastroenterology, Urology · 21 CFR 876.5250

Recalls & enforcement

Class IIOngoing2024-12-23
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Class IITerminated2021-02-11
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Hollister Medical India Private Limited (FEI 3008191244) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008191244-hollister-medical-india-private-limited/

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