Verathon recalls
Verathon appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2024-06-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2012-12-19 to 2024-06-12 |
| By agency | FDA Device (14) |
| By classification | Class II (9), Class I (4), Class III (1) |
| By status | terminated (11), ongoing (3) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description:…
FDA Device · Class II · 2024-06-12 · Verathon
Reason: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. - Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
FDA Device · Class II · 2024-06-12 · Verathon
Reason: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. - GlideScope Go Monitors
FDA Device · Class III · 2021-08-11 · Verathon
Reason: Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality. - BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively
FDA Device · Class II · 2020-12-09 · Verathon
Reason: Due to a change in handle material and process, probe handle may crack. - GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch…
FDA Device · Class I · 2020-07-15 · Verathon
Reason: When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video… - GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
FDA Device · Class II · 2020-03-18 · Verathon
Reason: 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. - It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg)
FDA Device · Class II · 2017-04-26 · Verathon
Reason: Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)). - GlideScope Titanium Single-Use Video Laryngoscope
FDA Device · Class I · 2016-03-16 · Verathon
Reason: 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… - BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451
FDA Device · Class II · 2016-03-16 · Verathon
Reason: The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these de… - GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5)
FDA Device · Class II · 2016-02-24 · Verathon
Reason: Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this… - GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007
FDA Device · Class II · 2015-12-23 · Verathon
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 n… - GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115
FDA Device · Class II · 2015-12-23 · Verathon
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 n… - GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngos…
FDA Device · Class I · 2013-06-26 · Verathon
Reason: Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intub… - The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a re…
FDA Device · Class I · 2012-12-19 · Verathon
Reason: Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.