RegWardenFDA facility compliance records
Company

GIVEN IMAGING INC.

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

Recalls by year

FDA actions on record by year2025: 1 recalls; 2026: 1 recalls201720182019202020212022202320241202512026
  • Recalls (2)

Registered facilities (2)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “GIVEN IMAGING INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10091555-given-imaging-inc/

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