RUSCH IPN039531Recalls & reported problems

Teleflex Incorporated · RUSCH® Polaris™ STUBBY FIBER OPTIC DISPOSABLE LARYNGOSCOPE HANDLE WITH BATTERIES · Class 1

All models of RUSCH (220)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Feb 18, 2021Terminated
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
Z-1294-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`14026704662576`
Brand	RUSCH
Model	IPN039531
Catalog no.	44403
Company	Teleflex Incorporated
Product code	CCW · LARYNGOSCOPE, RIGID
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 26, 2022

Device type (GMDN): Laryngoscope handle, single-use

A clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Other LARYNGOSCOPE, RIGID devices

McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls202 reports
McGRATH MAC 300-000-000
Covidien LP · LARYNGOSCOPE, RIGID
1 recall1 death205 reports
n.a. 8404HX
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
242 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 deaths192 reports
McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls90 reports
n.a. 8404BXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
141 reports
n/a 8404AXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
108 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
84 reports

All LARYNGOSCOPE, RIGID devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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