O-Two Adult Ventilation Timer — Class II medical device recall Z-2705-2017
Terminated recall by O-Two Medical Technologies, Inc., reported 2017-07-19, distributed nationwide. Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reporte
| Recall number | Z-2705-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | O-Two Medical Technologies, Inc., Mississauga, Canada |
| Recall initiated | 2015-06-23 |
| Classified | 2017-07-10 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2017-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DK, FI |
| Reason classes | labeling, device malfunction |
| Lot numbers | 078734, 079810, 081071, 130117, 140411, 140506, 140719, 141117 |
| Model numbers | 01BM1000, 01BM1000-CS, 01BM3201-MOTL-CS, 01BM3201-MOTP-CS |
| Expiration dates | 2016-07-20 |
Product
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
Reason for recall
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
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-2705-2017. 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.