FDA Medical Device Recalls (openFDA)
Bomimed: BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
- Recall number
- Z-3238-2017
- Recalling firm
- Bomimed
- Product
- BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
- Status
- Terminated
- Initiated
- 2017-07-13
- Posted
- not on file
- Terminated
- 2021-04-01
- Reason
- Potential for intermittent lighting (flickering) during use.
- Root cause
- Device Design
- Action
- A letter was sent to all the consignees via mail dated July 13, 2017 informing of the recall due to Length variation of the battery contact inside the handle due to manufacturing/assembly variation may potentially cause an intermittent electrical connection resulting in flickering light. Complete the bottom section and return by email to regulatory@bomimed.com to confirm this notice has been received and understood. Check functionality of the light for each handle by engaging a blade and applying pressure to simulate use. Complete this task prior to use. Contact BOMImed for replacements if intermittent lighting is present. Replacement product orders will be organized in a manner to assist in covering all affected customers needs. Contac: Trina Friesen Quality Assurance & Regulatory Manager Tel: 800-667-6276 ext.234 Fax: 877-435-6984 regulatory@bomimed.com
- Quantity
- 680 (US) 2,220 (OUS)
- Distribution
- IL. PA. and WA CANADA
- Lot, serial or model codes
- Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3003213883
- Firm city
- Winnipeg
- 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