FDA Medical Device Recalls (openFDA)
Teleflex Medical: Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
- Recall number
- Z-1225-06
- Recalling firm
- Teleflex Medical
- Product
- Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
- Status
- Terminated
- Initiated
- 2006-06-15
- Posted
- 2006-07-13
- Terminated
- 2009-08-28
- Reason
- Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.
- Root cause
- Component change control
- Action
- Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
- Quantity
- 1,408 laryngoscopes
- Distribution
- Nationwide and Canada, Colombia, Costa Rica and Chile.
- Lot, serial or model codes
- catalog number 004413300, any lot number greater than and including 050901. Please note: the lot number is located at the top of the handle, where the laryngoscope hinge attaches to the blade.
- 510(k) numbers
- ["K883414"]
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3004959265
- Firm city
- Bannockburn
- Firm state
- IL
- Firm country
- not on file
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