Z-0420-2016Class II

GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The...

Name: Z-0420-2016 GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The...
Creator: Verathon, Inc.
Published: 2015-11-30
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2015-11-30 / Terminated / root cause: manufacturing process

FDA source

Verathon, Inc. began a recall of GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and... on 2015-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0420-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Posted: 2015-12-15
Terminated: 2016-08-22
Recalling firm: Verathon Inc.
Product: GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.
Product code: CCW Laryngoscope, Rigid
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.
Root cause tag: manufacturing process
FDA 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, [email protected] . 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 in commerce: total 612 units (394 units in the US and 218 units outside the 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.
Product codes and lots: ***ADDITIONAL 72 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15 *** LG151991, LG152083, LG152084, LG152180, LG152181, LG152183, LG152184, LG152185, LG152186, LG152187, LG152188, LG152189, LG152191, LG152192, LG152193, LG152194, LG152195, LG152196, LG152197, LG152198, LG152199, LG152201, LG152202, LG152203, LG152204, LG152205, LG152206, LG152207, LG152208, LG152209, LG152210, LG152216, LG152217, LG152218, LG152219, LG152220, LG152221, LG152222, LG152223, LG152224, LG152225, LG152226, MD151720, MD151835, MD151879, MD151880, MD151881, MD151882, MD151883, MD151885, MD151886, MD151887, MD151888, MD151891, MD151895, MD151896, MD151897, MD151898, MD151900, MD151901, MD151902, MD151903, MD151904, MD151921, MD151923, MD151924, MD151925, MD151926, MD151927, MD151928, XL151554, and XL151569. ****SERIAL NUMBERS OF UNITS IN THE US***************************************** LG151858, LG151859, LG151860, LG151861, LG151862, LG151863, LG151866, LG151868, LG151869, LG151870, LG151872, LG151873, LG151874, LG151875, LG151876, LG151877, LG151878, LG151880, LG151881, LG151882, LG151883, LG151884, LG151885, LG151890, LG151891, LG151892, LG151893, LG151894, LG151895, LG151896, LG151898, LG151899, LG151900, LG151901, LG151903, LG151904, LG151906, LG151907, LG151908, LG151909, LG151917, LG151918, LG151919, LG151920, LG151921, LG151922, LG151923, LG151924, LG151925, LG151926, LG151927, LG151928, LG151930, LG151931, LG151932, LG151933, LG151934, LG151935, LG151936, LG151937, LG151938, LG151939, LG151940, LG151941, LG151942, LG151943, LG151944, LG151945, LG151946, LG151947, LG151948, LG151949, LG151952, LG151953, LG151954, LG151955, LG151957, LG151959, LG151961, LG151963, LG151964, LG151965, LG151967, LG151969, LG151972, LG151977, LG151978, LG151979, LG151981, LG151984, LG151985, LG151986, LG151987, LG151988, LG151989, LG151990, LG151993, LG151994, LG151996, LG151997, LG151998, LG152000, LG152001, LG152002, LG152003, LG152004, LG152005, LG152006, LG152007, LG152008, LG152009, LG152010, LG152011, LG152012, LG152013, LG152014, LG152015, LG152016, LG152017, LG152018, LG152019, LG152020, LG152021, LG152022, LG152023, LG152024, LG152025, LG152026, LG152027, LG152028, LG152029, LG152030, LG152032, LG152033, LG152034, LG152036, LG152037, LG152038, LG152039, LG152044, LG152045, LG152046, LG152048, LG152049, LG152050, LG152051, LG152052, LG152053, LG152054, LG152058, LG152059, LG152060, LG152061, LG152062, LG152063, LG152065, LG152066, LG152067, LG152069, LG152071, LG152072, LG152073, LG152074, LG152076, LG152079, LG152081, LG152082, LG152085, LG152086, LG152087, LG152088, LG152089, LG152090, LG152092, LG152093, LG152094, LG152095, LG152096, LG152097, LG152098, LG152099, LG152100, LG152101, LG152102, LG152103, LG152104, LG152105, LG152106, LG152107, LG152113, LG152114, LG152115, LG152116, LG152117, LG152118, LG152119, LG152120, LG152121, LG152122, LG152124, LG152126, LG152132, LG152133, LG152134, LG152135, LG152140, LG152141, LG152142, LG152143, LG152144, LG152145, LG152146, LG152147, LG152148, LG152150, LG152152, LG152153, LG152154, LG152155, LG152156, LG152158, LG152159, LG152160, LG152161, LG152162, LG152163, LG152164, LG152170, LG152171, LG152172, LG152173, LG152178, LG152179, MD151705, MD151706, MD151707, MD151708, MD151709, MD151710, MD151711, MD151712, MD151713, MD151717, MD151718, MD151719, MD151727, MD151728, MD151729, MD151730, MD151731, MD151733, MD151744, MD151745, MD151746, MD151748, MD151749, MD151750, MD151752, MD151753, MD151754, MD151756, MD151757, MD151758, MD151760, MD151761, MD151762, MD151766, MD151767, MD151768, MD151769, MD151770, MD151771, MD151772, MD151773, MD151774, MD151775, MD151776, MD151779, MD151780, MD151781, MD151782, MD151783, MD151785, MD151786, MD151787, MD151788, MD151789, MD151792, MD151793, MD151794, MD151795, MD151796, MD151797, MD151798, MD151799, MD151800, MD151801, MD151802, MD151803, MD151804, MD151805, MD151806, MD151807, MD151808, MD151812, MD151817, MD151818, MD151819, MD151822, MD151823, MD151824.MD151825, MD151826, MD151827, MD151828, MD151829, MD151830, MD151831, MD151832, MD151833, MD151834, MD151837, MD151839, MD151840, MD151841, MD151842, MD151843, MD151844, MD151845, MD151846, MD151847, MD151848, MD151850, MD151851, MD151852, MD151853, MD151854, MD151855, MD151856, MD151857, MD151858, MD151860, MD151861, MD151862, MD151863, MD151864, MD151865, MD151866, MD151868, MD151869, MD151870, MD151871, MD151872, MD151875, MD151876, MD151877, MD151878, MD151931, MD151932, XL151543, XL151545, XL151546, XL151547, XL151548, XL151549, XL151551, XL151552, XL151556, XL151557, XL151558, XL151559, XL151560, XL151562, XL151563, XL151564, XL151566, XL151567, XL151568, XL151570, and XL151572. ****SERIAL NUMBERS OF UNITS OUTSIDE THE US******************* LG151886, LG151887, LG151888, LG151905, LG151910, LG151911, LG151912, LG151913, LG151914, LG151915, LG151916, LG151950, LG151951, LG151958, LG151960, LG151962, LG151966, LG151973, LG151974, LG151975, LG151976, LG151980, LG151982, LG151983, LG151992, LG151995, LG151999, LG152031, LG152035, LG152040, LG152041, LG152042, LG152043, LG152047, LG152055, LG152056, LG152057, LG152064, LG152075, LG152077, LG152078, LG152080, LG152091, LG152108, LG152109, LG152110, LG152111, LG152112, LG152123, LG152125, LG152127, LG152128, LG152129, LG152130, LG152131, LG152136, LG152137, LG152138, LG152139, LG152149, LG152151, LG152157, LG152165, LG152167, LG152168, LG152169, LG152174, LG152175, LG152176, LG152177, LG152211, LG152212, LG152213, LG152214, LG152215, LG152227, LG152228, LG152229, LG152231, LG152232, MD151685, MD151686, MD151687, MD151688, MD151689, MD151690, MD151691, MD151692, MD151693, MD151694, MD151695, MD151696, MD151697, MD151698, MD151699, MD151700, MD151701, MD151702, MD151703, MD151704, MD151714, MD151715, MD151716, MD151721, MD151722, MD151723, MD151724, MD151725, MD151732, MD151734, MD151735, MD151736, MD151737, MD151738, MD151740, MD151741, MD151742, MD151755, MD151759, MD151763, MD151764, MD151765, MD151777, MD151778, MD151784, MD151790, MD151791, MD151809, MD151810, MD151811, MD151813, MD151814, MD151815, MD151816, MD151820, MD151821, MD151859, MD151873, MD151874, MD151905, MD151906, MD151907, MD151908, MD151909, MD151910, MD151911, MD151912, MD151914, MD151915, MD151916, MD151917, MD151918, MD151919, MD151920, MD151929, MD151930, XL151544, XL151550, XL151561, and XL151571.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0420-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0420-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15
Z-0421-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15

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)