Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc. is recalling 7,401 Rusch Greenlite laryngoscopes because the welded joint may break during 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 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 (breaking at a welded joint) that poses a risk of harm during a medical 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 recalling 7,401 units of the Rusch Greenlite laryngoscope (Product Code: 004550004, GTIN: 14026704663085). The device is intended to allow direct visualization of the laryngeal structure during tracheal intubation. The recall is due to a defect where the device may break at the point of a welded joint.
The affected lots are 1812441, 1901441, 1903441, 1905441, 1906441, 1907441, and 1909441. These units were distributed nationwide across the United States, including the District of Columbia and 48 states.
Healthcare facilities and consumers should stop using the affected laryngoscopes immediately and contact Teleflex Medical Inc. for instructions on returning the devices.
The recalled product
- Product
- Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (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
- Hazard
- Affected units
- 7,401
Distribution
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.
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