The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1294-2021·Announced 2021-03-31

Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking

Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.

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 involves a medical device with a structural defect (cracking/breaking) that poses a risk of harm during a critical procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Teleflex Medical Inc. is voluntarily recalling specific models of the Rusch Polaris laryngoscope. The recall is being conducted because customers have reported that the laryngoscope handles develop cracks and/or break at the hinge. The affected products are intended to allow direct visualization of the laryngeal structure and are used during tracheal intubation.

The recall covers approximately 157,150 units, with 156,980 units distributed in the United States and 170 units distributed outside the US. The affected models are 44401, 44402, and 44403, across various specific lot numbers. Distribution was nationwide in the US and included Canada.

Healthcare providers and consumers should stop using the affected laryngoscopes immediately. Teleflex is the recalling firm responsible for managing this recall.

The recalled product

Product
RUSCH¿ POLARIS" Laryngoscope - Product Usage: 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

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 (16)

  • Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556
  • lots 197
  • 19A
  • 19F
  • 19J
  • 19P
  • 19W
  • 205
  • 207
  • 20C
  • 20H
  • 20T)
  • Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563
  • 20M
  • Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570
  • 20T).

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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