Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 27,341 units distributed nationwide.
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 is classified as FDA Class II. The hazard involves a structural defect (welded joint breakage) in a medical device used during a critical procedure, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical Inc is recalling 27,341 units of Rusch Greenlite laryngoscopes (Product Code: 0004550003, GTIN: 14026704663078). 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 units were distributed nationwide, including in the District of Columbia and the following states: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. The specific lot numbers affected are 1812431, 1901431, 1902431, 1903431, 1904431, 1905431, 1906431, 1907431, 1908431, and 1909431.
This recall is classified as FDA Class II. Healthcare facilities and users should stop using the affected laryngoscopes and contact Teleflex Medical Inc for further instructions on return or replacement.
The recalled product
- Product
- Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (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
- 27,341
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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