CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report

Rusch Greenlite Product recalled by Teleflex Medical

Teleflex Medical is recalling Rusch Greenlite, distributed nationwide in the US. The recall was initiated on 6 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Batch Numbers: 1906321 1907321 1908321 1909321

Quantity recalled20600 units

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-2729-2020
FDA event ID: 85996
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class II
Status: Terminated
Recall initiated: 6 Jul 2020
FDA classified: 28 Jul 2020
Reported: 5 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

6 Jul 2020	Recall initiated by company
28 Jul 2020	Classified by FDA	+22 days
5 Aug 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Breaking at the point of a welded joint

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution 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, AK.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Breaking at the point of a welded joint

Which lots are affected?

Lot/Batch Numbers: 1906321 1907321 1908321 1909321

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 85996

This product is part of a recall event; the main page for the event is Rusch Greenlite Product recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide
5 Aug 2020	CLASS II	Rusch Greenlite Product recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide

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All 235

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