Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (welded joint breakage) in a medical device used during tracheal intubation, which meets the rubric criteria for a structural defect or significant injury risk.
Plain-English summary
Teleflex Medical Inc. is recalling 20,600 units of the Rusch Greenlite laryngoscope (Product Code: 004551002, GTIN: 14026704663115). The device is intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
The recall was initiated because the device may break at the point of a welded joint. This defect could compromise the structural integrity of the laryngoscope during use.
The affected lots are 1906321, 1907321, 1908321, and 1909321. The products were distributed nationwide, including in the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WV. Healthcare facilities and consumers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (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
- 20,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Batch Numbers: 1906321 1907321 1908321 1909321
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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