Given Imaging Bravo¿¿ pH capsule delivery device — Class II medical device recall Z-1620-2016
Terminated recall by Covidien LLC, reported 2016-05-18, distributed nationwide. Potential of an allergic reaction in a patient with nickel sensitivity.
| Recall number | Z-1620-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CY, GR, HK, IL, KR, MX, PA, SG, SV, TH |
| Quantity | 1,305 units |
| Model numbers | FGS-0313 |
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 for recall
Potential of an allergic reaction in a patient with nickel sensitivity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1620-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.