Facility

GIVEN IMAGING LTD.

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

Key facts

2recalls · worst Class I

—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)	3003348376
Establishment type	Manufacture Medical Device
Location	2 Hacarmel St. Yoqneam Northern, IL 20692
Registration status	Active · expires 2026
Parent company	GIVEN IMAGING INC. (owner-operator 10091555)
Brand names	SmartPill Capsule Calibration Fluid; SmartPill GI Monitoring System, version 2; SmartPill Docking Station; SmartPill pH.p Capsule; Activation Fixture; SmartPill MotiliGI Software; SmartPill Data Receiver

Activity by year

Recalls (2)

Devices registered here (1)

Gastrointestinal Motility System, Capsule
Product code NYV (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1725

Recalls & enforcement

Class IOngoing2026-08-06
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies …
Class IOngoing2025-06-03
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.

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. “GIVEN IMAGING LTD. (FEI 3003348376) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003348376-given-imaging-ltd/

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