CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Rusch Greenlite Single-Use Metal Laryngoscope Blade recalled

Teleflex Medical is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System, distributed nationwide in the US. The recall was initiated on 9 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code 004551004; Lot Numbers 1812341, 1903341
Quantity recalled338,928 (199,018 US and 139,910 OUS) for all products

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1117-2020
FDA event ID
84702
Recalling firm
Teleflex Medical, Morrisville, NC
Classification
Class II
Status
Terminated
Recall initiated
9 Jan 2020
FDA classified
7 Feb 2020
Reported
19 Feb 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction

Timeline

9 Jan 2020Recall initiated by company
7 Feb 2020Classified by FDA+29 days
19 Feb 2020Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System

Where it was distributed

Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218

Nationwide MissouriPuerto RicoVirginia

Questions about this recall

Why was it recalled?

The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.

Which lots are affected?

Product Code 004551004; Lot Numbers 1812341, 1903341

Where was it sold?

Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84702
ReportedClassRecallCompanyReasonWhere
CLASS IIRusch Greenlite Single-Use Metal Laryngoscope Blade recalledTeleflex MedicalDevice MalfunctionNationwide

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