FDA Medical Device Recalls (openFDA)
O-Two Medical Technologies, Inc.: 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
- Recall number
- Z-2705-2017
- Recalling firm
- O-Two Medical Technologies, Inc.
- 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
- Status
- Terminated
- Initiated
- 2015-06-23
- Posted
- 2017-06-22
- Terminated
- 2017-09-01
- Reason
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- O-Two Medical Technologies sent a Recall Notification on June 23, 2015, to all affected customers. The letter notified customers of the malfunctioning device, description, brand name, model/catalog number, target population, quantity, Lot Number, Shelf Life, hazard potential, and an image of labeling. The letter also provided instructions to customer for action and response. Customers were to return the affected product and O-Two will ship back the unaffected medical devices. Customers were instructed to acknowledge receipt of this recall notice by fax to 1-905-677-2035. For questions regarding this recall call 905-677-9410 or 1-800-387-3405.
- Quantity
- 4382 units (4082 units distributed USA)
- Distribution
- Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
- Lot, serial or model codes
- Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JBS
- Firm FEI
- 3002807836
- Firm city
- Mississauga
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28