FDA Device recall Z-1620-2016
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack by Covidien, citing potential of an allergic reaction in a patient with nickel sensitivity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1620-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Reason
Potential of an allergic reaction in a patient with nickel sensitivity.
Identifiers
| code_info | All lot numbrs |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1620-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.