Recall Z-2047-2025— Given Imaging Ltd.

Name: FDA recall Z-2047-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-03

Class I · Ongoing

Class I FDA medical device recall by Given Imaging Ltd., initiated 2025-06-03. It names one FDA 510(k) clearance: K102543. 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: 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..

Recalling firm: Given Imaging Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2025-06-03
Firm location: Yokne'Am Ilit, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.·cleared 2010-12-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.