Z-1035-2016Class I

GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope...

Name: Z-1035-2016 GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope...
Creator: Verathon, Inc.
Published: 2016-01-29
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2016-01-29 / Terminated / root cause: manufacturing process

FDA source

Verathon, Inc. began a recall of GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged... on 2016-01-29. FDA classified it as Class I and gives the reason as "The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up...". 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-1035-2016
Classification: Class I
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-03-11
Terminated: 2017-03-01
Recalling firm: Verathon Inc.
Product: GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) 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.
Product code: CCW Laryngoscope, Rigid
Reason for recall: The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Verathon, began mailing the "URGENT: MEDICAL DEVICE RECALL" GLIDESCOPE VIDEO LARYNGOSCOPE TITANIUM SINGLE-USE BLADES letter to their consignees on January 29, 2016. The letter describes the product, problem and actions to be taken. Verathon will instruct the company's foreign distributors to communicate the Customer Recall Letter to their international customers. Verathon has contracted with a business services company, Stericycle, to coordinate the initial consignee communications in the United States, Australia and Canada. Stericycle will send the Customer Recall Letters, and conduct consignee follow-up communications for return of the Recall Response Forms. Verathon will replace all affected GlideScope Titanium Single Use (SU) blades that remain in your facility's inventory with new product that has been passed the enhanced screening test for video flickering. Customers were advised to take the following actions: -Fill out the attached Recall Response Form and return it to Verathon by fax (888) 943-5170, or email, [email protected]. Please return the form even if you do not have any blades subject to the recall. If consignees need to expedite a product replacement contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). The firm has live agent support Monday through Friday from 8:00am to 5:00pm Eastern Time. Consignees can also send email to [email protected]. Consignees who have any questions about this Product Recall, please contact Verathon representative or call (888) 943-4207 (U.S. and Canada) or send email to [email protected]. Please report any suspected malfunction or adverse event related to any GlideScope Video Laryngoscope devices to Verathon Customer Care at the telephone numbers above and to FDA's MedWatch Program (1-800-FDA-1088 or www.fda.gov/medwatch).
Quantity in commerce: 7733 units (6377 units in the US and 1356 units International)
Distribution: Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.
Product codes and lots: LOT Number ranges: -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1035-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1035-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10

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)