Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc. is recalling 29,740 Rusch Greenlite laryngoscopes because the welded joint 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 is classified as FDA Class II. The hazard involves a structural defect (breaking at a welded joint) in a device used during a critical medical procedure (tracheal intubation), which poses a risk of harm, but the source text does not report specific injuries or fatalities.
Plain-English summary
Teleflex Medical Inc. is recalling 29,740 units of the Rusch Greenlite laryngoscope (Product Code: 004551035, GTIN: 7290102156443). The recall is due to a defect where the device may break at the point of a welded joint. The laryngoscope is a medical device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
The affected units were distributed nationwide in the United States, including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, and AK. The specific lot numbers affected are 1811351, 1812351, 1901351, 1903351, 1904351, 1905351, 1906351, 1907351, 1908351, and 1909351.
Healthcare facilities and consumers should stop using these devices immediately and contact Teleflex Medical Inc. for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (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
- 29,740
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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