The Introes Pocket Bougie is an endotracheal tube introducer — Class II medical device recall Z-0067-2017
Terminated recall by Brathwaites Oliver Medical, reported 2016-10-19, distributed in AZ, CT, IL, IN, MA, MO, NC, NE…. The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubati
| Recall number | Z-0067-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brathwaites Oliver Medical, Winnipeg, Manitoba, Canada |
| Recall initiated | 2016-08-19 |
| Classified | 2016-10-11 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2019-07-19 |
| Distributed | AZ, CT, IL, IN, MA, MO, NC, NE, NY, OH, OR, PA, UT, WI |
| Countries outside the US | CA |
| Quantity | 760 units |
| Reason classes | device malfunction |
| Lot numbers | 101615 |
| Model numbers | OL-E12102 |
Product
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
Reason for recall
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
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-0067-2017. 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.