FDA Medical Device Recalls (openFDA)
Covidien: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
- Recall number
- Z-0169-2024
- Recalling firm
- Covidien
- Product
- McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-08-10
- Posted
- 2023-11-01
- Terminated
- not on file
- Reason
- Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
- Root cause
- Under Investigation by firm
- Action
- On August 10, 2023 Medtronic ( Parent company of Covidien) issued an Urgent via UPS. Medtronic ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots of McGRATH MAC 2 disposable laryngoscope blades. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in your inventory to Medtronic as described on the Customer Confirmation Form. 3. Please complete and return the enclosed Customer Confirmation Form even if you do not have unused inventory. 4. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. 5. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic: . Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or . Call FDA (800) FDA-1088 . Call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1
- Quantity
- 42,367
- Distribution
- US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates
- Lot, serial or model codes
- UDI: 10884521824386/ Lot # 22102001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- 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