Z-3090-2026Class I

Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack...

Name: Z-3090-2026 Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack...
Creator: Given Imaging Ltd.
Published: 2026-08-06
License: https://open.fda.gov/license/

Given Imaging Ltd. / initiated 2026-08-06 / Open, Classified

FDA source

Recall record

Recall number: Z-3090-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-09-11
Recalling firm: Given Imaging Ltd.
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.
Product code: FFT Electrode, Ph, Stomach
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.
FDA root cause: Nonconforming Material/Component
Action: On August 10, 2026, the firm notified consignees via "URGENT: MEDICAL DEVICE RECALL" letters. Please note this is a separate recall from that initiated in June 2025, which involved the same issue, but a different underlying cause. Customers were instructed to do the following: 1. Immediately identify and quarantine all unused and affected devices. 2. Return all product to Medtronic for replacement as described in the letter. 3. Complete and return the included customer response form to the firm via email: [email protected], even if you do not have unused affected inventory. 4. Notify all those who need to be aware within your organization, or those to whom affected product was transferred/distributed. 5. Maintain a copy of the recall letter for your records. If you have any questions regarding this communication, please contact your local Medtronic Representative or call 720-774-3454.
Quantity in commerce: 127,416
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.
Product codes and lots: Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3090-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3090-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10

Product code FFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)