Z-0494-2015Class II

McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched...

Name: Z-0494-2015 McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched...
Creator: Aircraft Medical Limited
Published: 2014-11-04
License: https://open.fda.gov/license/

Aircraft Medical Limited / initiated 2014-11-04 / Terminated

FDA source

Aircraft Medical Limited began a recall of McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use... on 2014-11-04. FDA classified it as Class II and gives the reason as "The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0494-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-02
Terminated: 2017-11-17
Recalling firm: Aircraft Medical Limited
Product: McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
Product code: CCW Laryngoscope, Rigid
Reason for recall: The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
FDA root cause: Component change control
Action: Aircraft Medical Limited sent a recall notification letter dated November 4, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its own stock and its customers' stock for the recalled products; 2) arrange for any remaining stock to be removed from use. Customers with any questions can contact Aircraft Medical by e-mail at [email protected].
Quantity in commerce: 40,900 blades (US); 16,000 blades (Foreign)
Distribution: Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
Product codes and lots: Product Code: 350-017-000. Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0494-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0494-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)