Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage
Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joints may break. The devices are used for tracheal intubation.
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 structural defect in a medical device used during a critical procedure (tracheal intubation). While no injuries are reported in the source text, the risk of harm from a broken device during use justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes (Product Code 004551004, GTIN 24026704553796) because the welded joints may break. The laryngoscope is a medical device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Approximately 350,779 units are affected by this recall. The affected lot numbers are 1811341, 1901341, 1902341, 1904341, 1905341, 1906341, 1907341, 1908341, and 1909341. The products were distributed nationwide across the United States, including in states such as Florida, California, Texas, and New York.
Healthcare facilities and consumers should stop using the affected laryngoscopes immediately. Users should contact Teleflex Medical Inc. for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (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
- Affected units
- 350,779
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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