Agency classClass IIOur severity:High FDA (Devices)·Z-2130-2014·Announced 2014-08-06

Teleflex Recalls RUSCH TruLite Disposable Laryngoscope Handles

Teleflex Medical is recalling RUSCH TruLite laryngoscope handles because the handle may heat up and melt the end cap.

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 risk of harm (melting end cap) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Teleflex Medical is recalling 6,246 units of RUSCH TruLite One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only. The affected products were distributed nationwide in the United States.

The recall was initiated because there is a possibility that the handle of the laryngoscope may heat up and melt the end cap. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare providers and consumers should stop using the affected products and contact Teleflex Medical for instructions on how to return or dispose of them. The recall covers specific product codes and lot numbers for Miller and Mac blade sizes, as detailed in the agency's structured product information.

The recalled product

Product: RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Manufacturer: Teleflex Medical
Category: Medical Device — Laryngoscope
Hazard: burn-injury
melting
Affected units: 6,246

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 (20)

Product Code: 004660000
(Size Miller 0)
Lot numbers: 1306602
1308602 & 1310602
Product Code: 004660001
(Size Miller 1)
Lot numbers: 1306612
1308612 & 1310612
Product Code: 004660002
(Size Miller 2)
Lot numbers: 1306622
1308622
1309622 & 1310622
Product Code: 004660003
(Size Miller 3)
Lot numbers: 1306632 & 1310632
Product Code: 004660004
(Size Miller 4)
Lot numbers: 1306642
1308642 & 1309642

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teleflex Medical

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