CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
Rusch Greenlite Single-Use Metal Laryngoscope Blade recalled
Teleflex Medical is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System, distributed nationwide in the US. The recall was initiated on 9 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1116-2020
- FDA event ID
- 84702
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2020
- FDA classified
- 7 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2020 | Recall initiated by company | |
| 7 Feb 2020 | Classified by FDA | +29 days |
| 19 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Where it was distributed
Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
Questions about this recall
Is Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System recalled?
Yes. Teleflex Medical recalled Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System on 9 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1116-2020.
Why was it recalled?
The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
Which lots are affected?
Product Code 004551003; Lot Numbers 1811331, 1902331, 1904331
Where was it sold?
Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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