Agency classClass IOur severity:Severe FDA (Devices)·Z-3090-2026·Announced 2026-09-16

Given Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure

Given Imaging is recalling Bravo CF capsule delivery devices because they may fail to attach to the esophagus or detach from the device, posing risks of aspiration and perforation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Given Imaging Ltd. is recalling Bravo CF capsule delivery devices, specifically the 5-pack (Product Number FGS-0635) and 1-pack (Product Number FGS-0636). These devices are used to attach a pH monitoring capsule to the esophagus. The recall covers 127,416 units with expiration dates prior to and including October 20, 2027, and lot numbers from 64553F up to and including 68912F.

The recall was initiated because the capsule may fail to attach to the esophagus or detach from the delivery device. This malfunction presents risks including patient aspiration or inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage or blood loss, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

The affected devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as in numerous international markets such as Argentina, Australia, Canada, China, France, Germany, India, and the United Kingdom. Consumers and healthcare providers should stop using the affected devices and contact Given Imaging Ltd. for further instructions.

The recalled product

Product: Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
Manufacturer: Given Imaging Ltd.
Category: Medical Device — Endoscopy / Diagnostic
Hazard: aspiration
perforation
airway-obstruction
hemorrhage
Affected units: 127,416

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

2027 (lot numbers from 64553F up to and including 68912F)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Given Imaging Ltd.

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Same hazard · aspiration