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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 13 FDA device recalls.

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DateProductReasonClassFirm
Apr 29, 2024 Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 ... Due to software issues, their is the potential for loss of image or a degradation of the image wh... Class II Verathon, Inc.
Apr 29, 2024 Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Sof... Due to software issues, their is the potential for loss of image or a degradation of the image wh... Class II Verathon, Inc.
Jul 1, 2021 GlideScope Go Monitors Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into ... Class III Verathon, Inc.
Sep 29, 2020 BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be us... Due to a change in handle material and process, probe handle may crack. Class II Verathon, Inc.
Jun 5, 2020 GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the Gli... When video laryngoscopy system users apply, twisting motions while connecting the blade in the HD... Class I Verathon, Inc.
Mar 31, 2019 GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of lo... Class II Verathon, Inc.
Jan 29, 2016 GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video l... The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy ... Class I Verathon, Inc.
Nov 30, 2015 GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0... Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due... Class II Verathon, Inc.
Nov 30, 2015 BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U27... The firm is providing customers with an updated Operations and Maintenance Manual for each of the... Class II Verathon, Inc.
Nov 30, 2015 GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-... Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due... Class II Verathon, Inc.
Apr 13, 2015 GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5... Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibil... Class II Verathon, Inc.
May 8, 2013 GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and... Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of p... Class I Verathon, Inc.
Oct 25, 2012 The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorpor... Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to p... Class I Verathon, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.