The Recall Desk
SevereFDA (Devices)·Z-2729-2020·Announced 2020-08-05

Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 units distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (welded joint breakage) in a medical device used during tracheal intubation, which meets the rubric criteria for a structural defect or significant injury risk.

Plain-English summary

Teleflex Medical Inc. is recalling 20,600 units of the Rusch Greenlite laryngoscope (Product Code: 004551002, GTIN: 14026704663115). The device is intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

The recall was initiated because the device may break at the point of a welded joint. This defect could compromise the structural integrity of the laryngoscope during use.

The affected lots are 1906321, 1907321, 1908321, and 1909321. The products were distributed nationwide, including in the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WV. Healthcare facilities and consumers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement.

The recalled product

Product
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (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
Affected units
20,600

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 (1)

  • Lot/Batch Numbers: 1906321 1907321 1908321 1909321

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 →

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