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 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 specific injuries are reported in the source text, the risk of device failure during use constitutes a high-risk product hazard where injury has not yet been reported.
Plain-English summary
Teleflex Medical Inc is recalling 301,085 units of Rusch Greenlite laryngoscopes (Product Code: 004551003, GTIN: 14026704663122). 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 lots are 1812331, 1901331, 1903331, 1905331, 1906331, 1907331, 1908331, and 1909331. The products 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.
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: 004551003 GTIN: 14026704663122 (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
- Category
- Medical Device — Laryngoscope
- Affected units
- 301,085
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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