DeviceSignal · Recall classified
Given Imaging Ltd.
FDA classified a device recall on 2026-09-10 · Class I · Z-3090-2026
EventRecall classified
Effective2026-09-10
ClassificationClass I
On 2026-09-10 the FDA classified a device recall from Given Imaging Ltd. as Class I. Product: Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule…. Recall Z-3090-2026. The firm initiated it on 2026-08-06. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3090-2026
- Classification
- Class I
- Classified on
- 2026-09-10
- Initiated on
- 2026-08-06
- Firm
- Given Imaging Ltd.
- 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.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3090-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
9ff2874870929f6e064939320638e8b34ebf844fba749195c6b033c55b804677- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)