FDA Medical Device Recalls (openFDA)
Sun Med, Inc.: Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
- Recall number
- Z-0459-2009
- Recalling firm
- Sun Med, Inc.
- Product
- Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
- Status
- Terminated
- Initiated
- 2007-04-27
- Posted
- 2008-12-24
- Terminated
- 2010-07-06
- Reason
- A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.
- Root cause
- Device Design
- Action
- SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.
- Quantity
- 2,682 boxes (20 per box)
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lots: Gj, Ha
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 1314417
- Firm city
- Largo
- Firm state
- FL
- 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
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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