CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report

GlideScope AVL Video Laryngoscope (AVL) recalled by Verathon

Verathon is recalling GlideScope AVL Video Laryngoscope (AVL), distributed nationwide in the US. The recall was initiated on 30 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date 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.

Quantity recalled448 units (189 units in US and 259 units outside US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0421-2016
FDA event ID: 72642
Recalling firm: Verathon, Bothell, WA
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2015
FDA classified: 15 Dec 2015
Reported: 23 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Patient Monitors

Timeline

30 Nov 2015	Recall initiated by company
15 Dec 2015	Classified by FDA	+15 days
23 Dec 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

***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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72642

Reported	Class	Recall	Company	Reason	Where
23 Dec 2015	CLASS II	GlideScope Video Laryngoscope (GVL) recalled by Verathon	Verathon	Processing Deviation	Nationwide

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