Agency classClass IIOur severity:High FDA (Devices)·Z-2726-2020·Announced 2020-08-05

Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall affects 75,320 units distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (breaking at a welded joint) in a medical device used during a critical procedure (tracheal intubation), representing a risk of harm where injury has not yet been reported in the source text.

Plain-English summary

Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes (Product Code: 004550002, GTIN: 14026704663061) due to a defect where the device may break at the point of a welded joint. The laryngoscope is a medical device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

The recall involves 75,320 units. The affected lot numbers are 1811421, 1812421, 1901421, 1904421, 1905421, 1906421, 1907421, 1908421, and 1909421. The products were distributed nationwide, including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, and AK.

Healthcare providers and facilities should stop using the affected laryngoscopes and contact Teleflex Medical Inc. for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Manufacturer: TELEFLEX MEDICAL INC
Category: Medical Device — Surgical Instruments
Hazard: structural-defect
device-failure
Affected units: 75,320

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · TELEFLEX MEDICAL INC

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Same hazard · structural defect