Recall Register

Food, drugs, devices › Verathon, Inc.

Device recall: GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03

FDA enforcement event 84329 · Class II · initiated 31 Mar 2019 · status Terminated · terminated 14 Dec 2021

DeviceVoluntary: Firm initiated1 product recordBothell, WA

FDA enforcement event 84329 is a device recall by Verathon, Inc. of Bothell, WA, initiated 31 Mar 2019 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 14 Dec 2021. Initiation: voluntary: firm initiated. Verathon, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Verathon, Inc., Bothell, WA.

Reason for recall

"A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades."

Distribution

"US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada"

Product records

Recall numberProductQuantityClassStatusReport date
Z-1471-2020GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03239 manualsClass IITerminated18 Mar 2020

Context

88%of 2019 device events are Class II968 events that year
1product record in this eventfirm median: 1
12events on this register for the firm

Other enforcement events for Verathon, Inc.

InitiatedProduct (first record)TypeClassRecords
29 Apr 2024Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized MonitorDeviceClass II2
1 Jul 2021GlideScope Go MonitorsDeviceClass III1
29 Sep 2020BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the blDeviceClass II1
5 Jun 2020GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA:DeviceClass I1
3 Mar 2017It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of DeviceClass II1
29 Jan 2016GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium SysDeviceClass I1
30 Nov 2015BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: DeviceClass II1
30 Nov 2015GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consDeviceClass II2
13 Apr 2015GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope iDeviceClass II1
8 May 2013GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideSDeviceClass I1

All 12 events for Verathon, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Dec 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.