# FDA recall Z-2047-2025

> **Given Imaging Ltd.** · Class I · device recall initiated 2025-06-03.

## Product

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

## Reason for recall

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.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-2047-2025
- **Recalling firm:** Given Imaging Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-03
- **Report date:** 2025-07-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2047-2025

## Citation

> AI Analytics. FDA recall Z-2047-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2047-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*