The Recall Desk
SevereFDA (Devices)·Z-1116-2020·Announced 2020-02-19

Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

Teleflex Medical is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a medical device used inside a patient's mouth, which poses a significant risk of injury.

Plain-English summary

Teleflex Medical Inc. is recalling the Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System. The recall involves 338,928 units, including 199,018 in the United States and 139,910 outside the U.S. The affected product codes are 004551003, and the specific lot numbers are 1811331, 1902331, and 1904331.

The products are being recalled due to reports that the blades broke at the point of a welded joint. This breakage occurred either prior to use during setup or during use inside the patient's mouth. The FDA has classified this as a Class II recall.

The products were distributed nationwide in the United States and to Puerto Rico, as well as to more than 20 countries outside the U.S. Specific distribution included the VAMC - Kansas City MO. Healthcare facilities should stop using the affected lots and contact Teleflex Medical for further instructions.

The recalled product

Product
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Surgical Instruments
Hazard

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 (4)

  • Product Code 004551003
  • Lot Numbers 1811331
  • 1902331
  • 1904331

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

Related recalls

Same manufacturer · TELEFLEX MEDICAL INC

See all →

Same hazard · structural failure

See all →