Z-0169-2024Class II

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Name: Z-0169-2024 McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Creator: Covidien
Published: 2023-08-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-08-10 / Open, Classified

FDA source

Covidien began a recall of McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only on 2023-08-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0169-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-11-01
Recalling firm: Medtronic, Inc.
Product: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Product code: CCW Laryngoscope, Rigid
Reason for recall: 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.
FDA 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 in commerce: 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
Product codes and lots: UDI: 10884521824386/ Lot # 22102001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0169-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-01
Z-0169-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-01

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)