Agency classClass IIOur severity:Severe FDA (Devices)·Z-1117-2020·Announced 2020-02-19

Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

Teleflex Medical Inc. is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a medical device used inside a patient, which aligns with the rubric criteria for 'Severe' severity involving structural defects or significant injury risks.

Plain-English summary

Teleflex Medical Inc. is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades for Fiber Optic Systems. The recall involves 338,928 units, including 199,018 units in the United States and 139,910 units outside the U.S. The affected products are identified by Product Code 004551004 and Lot Numbers 1812341 and 1903341.

The recall was initiated due to reports that the blades broke at the point of a welded joint. This breakage occurred either prior to use during setup or during use inside the patient's mouth. The products were distributed nationwide in the U.S. and to Puerto Rico, as well as to more than 20 countries outside the U.S. Specific distribution included the VAMC - Kansas City MO.

Healthcare facilities and consumers should stop using the affected laryngoscope blades immediately. Users should contact Teleflex Medical Inc. for instructions on returning the products or obtaining replacements. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Manufacturer: TELEFLEX MEDICAL INC
Category: Medical Device — Surgical Instruments
Hazard: structural-failure
breakage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Product Code 004551004
Lot Numbers 1812341
1903341

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by TELEFLEX MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · TELEFLEX MEDICAL INC

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Same hazard · structural failure