Verathon, Inc.: GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

Recall number

Z-0421-2016

Recalling firm

Verathon, Inc.

Product

GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

Status

Terminated

Initiated

2015-11-30

Posted

2015-12-15

Terminated

2016-08-22

Reason

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Root cause

Process control

Action

The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15. **************************************************************************************** Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees. Verathon will, at no cost to you, test your GlideScope GVL and/or AVL blades that fall within the serial number ranges identified to determine whether the blades exhibit the defect that may result in separation of the blade. For all blades that we determine to exhibit this defect, Verathon will replace the blade, free of charge, with a blade of the same model and size. If the blade passes the testing without any evidence of the defect, we will return it to you in its current condition. Please note that this testing will not return blades to their original, factory condition. Verathon will provide you with a loaner blade for each blade in your possession that is subject to this recall, so you will not experience any interruption in use of your GlideScope system. To comply with this recall notice for the affected models and serial numbers of GlideScope GVL and A VL blades, please take the following actions: " Fill out the attached Recall Response Form and return it to Verathon by fax, (425) 883-2896, or email, CSNotifications@verathon.com . Please return the form even if you do not have any blades subject to the recall. " Contact Customer Care to arrange for delivery of a loaner blade and return of your recalled blade. Customer Care will issue you an "RMA" number and arrange for shipment of a loaner blade. Do not send us your current blade(s) until you receive the loaner blade(s). Should you have any questions about th

Quantity

448 units (189 units in US and 259 units outside US)

Distribution

Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.

Lot, serial or model codes

***ADDITIONAL 23 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15***  AD145054, AD151509, AD151510, AD151511, AD151512, AD151514, AD151516, AD151517, AD151518, AD151519, AD151520, AD151521, AD151522, AD151523, AD151526, AE151507, AE151529, AE151542, AE151543, AE151544, AF151517, AF151518, and AF151522.   ****SERIAL NUMBERS OF UNITS IN THE US***************************************** AD141605, AD141610, AD141614, AD141615, AD141618, AD141621, AD141622, AD141623, AD141624, AD141646, AD141647, AD141651, AD141652, AD141653, AD141654, AD141655, AD141674, AD141684, AD145000, AD145001, AD145005, AD145006, AD145007, AD145008, AD145010, AD145011, AD145012, AD145013, AD145014, AD145015, AD145027, AD145028, AD145029, AD145030, AD145031, AD145035, AD145036, AD145037, AD145040, AD145041, AD145042, AD145043, AD145044, AD145045, AD145046, AD145047, AD145048, AD145050, AD145051, AD145052, AD145057, AD145064, AD145065, AD145066, AD145069, AD151504, AD151505, AD151535, AE141629, AE141631, AE141632, AE141633, AE141638, AE141639, AE141640, AE145011, AE145012, AE145013, AE145014, AE145015, AE145016, AE145017, AE145018, AE145019, AE145020, AE145021, AE145022, AE145023, AE145026, AE145027, AE145028, AE145032, AE145033, AE145034, AE145035, AE145036, AE145037, AE145038, AE145039, AE145040, AE146010, AE146011, AE146012, AE146013, AE146014, AE146015, AE146016, AE146017, AE146018, AE146019, AE146020, AE146021, AE146022, AE146023, AE146024, AE146025, AE146026, AE146027, AE146033, AE146034, AE146035, AE146036, AE146037, AE146038, AE146039, AE146040, AE146041, AE146042, AE146043, AE146047, AE146048, AE146051, AE146053, AE146054, AE151504, AE151505, AE151506, AE151513, AE151514, AE151515, AE151516, AE151517, AE151518, AE151519, AE151520, AE151522, AE151523, AE151524, AE151525, AE151526, AE151535, AE151538, AE151539, AE151540, AE151541, AF141570, AF141571, AF141580, AF141582, AF145006, AF145011, AF145015, AF146019, AF146029, AF146031, AF146032, AF146035, AF146036, AF146037, AF146038, AF151500, AF151502, AF151503, AF151504, AF151505, AF151506, AF151508, AF151510, AF151512, AF151515, and AF151516.   ****SERIAL NUMBERS OF UNITS OUTSIDE THE US**************** AD141603, AD141604, AD141607, AD141608, AD141609, AD141611, AD141612, AD141613, AD141617, AD141619, AD141620, AD141625, AD141626, AD141627, AD141628, AD141629, AD141631, AD141632, AD141633, AD141634, AD141635, AD141636, AD141637, AD141638, AD141639, AD141640, AD141641, AD141642, AD141643, AD141644, AD141645, AD141648, AD141650, AD141656, AD141657, AD141658, AD141659, AD141660, AD141661, AD141662, AD141663, AD141664, AD141665, AD141666, AD141667, AD141668, AD141669, AD141670, AD141671, AD141672, AD141673, AD141675, AD141676, AD141677, AD141678, AD141679, AD141680, AD141681, AD141682, AD141683, AD145002, AD145003, AD145016, AD145017, AD145018, AD145019, AD145020, AD145021, AD145022, AD145023, AD145024, AD145025, AD145026, AD145032, AD145033, AD145034, AD145038, AD145039, AD145049, AD145053, AD145055, AD145056, AD145058, AD145059, AD145060, AD145061, AD145062, AD145063, AD145068, AD145070, AD145071, AD145072, AD146000, AD146002, AD146003, AD146004, AD146005, AD146006, AD146007, AD146008, AD146009, AD146010, AD146011, AD146012, AD146013, AD146014, AD146015, AD151500, AD151501, AD151502, AD151503, AD151506, AD151507, AD151508, AE141630, AE141634, AE141635, AE141636, AE141637, AE141641, AE141642, AE141643, AE141644, AE141645, AE141646, AE141647, AE141648, AE141649, AE141650, AE141652, AE141653, AE141654, AE141655, AE141656, AE141657, AE141664, AE141665, AE141666, AE141667, AE141668, AE141669, AE145000, AE145001, AE145002, AE145003, AE145004, AE145005, AE145006, AE145007, AE145008, AE145009, AE145025, AE145029, AE145030, ae145031, AE146000, AE146001, AE146003, AE146004, AE146006, AE146007, AE146008, AE146009, AE146028, AE146029, AE146031, AE146032, AE146044, AE146045, AE146046, AE146052, AE151500, AE151501, AE151502, AE151503, AE151508, AE151509, AE151510, AE151511, AE151512, AE151521, AE151527, AE151528, AE151532, AE151533, AE151534, AE151536, AE151537, AE151545, AF141572, AF141573, AF141579, AF141581, AF141583, AF141585, AF141586, AF141587, AF141588, AF141589, AF145000, AF145001, AF145002, AF145003, AF145005, AF145007, AF145008, AF145009, AF145010, AF145013, AF145014, AF145016, AF145017, AF145018, AF145019, AF145020, AF145021, AF146000, AF146001, AF146002, AF146003, AF146004, AF146005, AF146006, AF146007, AF146008, AF146009, AF146010, AF146011, AF146012, AF146013, AF146014, AF146015, AF146016, AF146017, AF146018, AF146020, AF146021, AF146022, AF146023, AF146024, AF146025, AF146026, AF146027, AF146028, AF146030, AF146033, AF146034, AF151501, AF151507, AF151513, AF151514, AF151520, AF151521, and AF151525.

510(k) numbers

not on file

PMA numbers

not on file

Product code

CCW

Firm FEI

3022472

Firm city

Bothell

Firm state

WA

Firm country

not on file

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

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