# FDA recall Z-3090-2026

> **Given Imaging Ltd.** · Class I · device recall initiated 2026-08-06.

## 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.

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-3090-2026
- **Recalling firm:** Given Imaging Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-06
- **Report date:** 2026-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yokne'Am Ilit, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3090-2026

## Citation

> MORVS. FDA recall Z-3090-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-3090-2026. Source: US FDA. Licensed CC0.

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