Given Imaging Bravo CF Capsule Delivery Device Recall Over Detachment Risk

FDA recall: what the record actually shows

This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class I recall, with the stated reason "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 remaining in the patient.", distributed worldwide distribution. us nationwide including puerto rico; argentina, australia, austria, bahrain, brazil, bulgaria, canada, cayman islands, chile, china, czech republic, dominican republic, france, germany, greece, hong kong, india, ireland, israel, italy, kazakhstan, kenya, luxembourg, netherlands, new zealand, norway, panama, poland, portugal, singapore, south africa, spain, sweden, switzerland, taiwan, thailand, trinidad and tobago, united arab emirates, and united kingdom.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.