Z-1117-2020Class II

Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System

Name: Z-1117-2020 Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Creator: Teleflex Medical Inc
Published: 2020-01-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-01-09 / Terminated / root cause: manufacturing process

FDA source

TELEFLEX MEDICAL INC began a recall of Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System on 2020-01-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1117-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-09
Posted: 2020-02-07
Terminated: 2023-09-11
Recalling firm: Teleflex Medical
Product: Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Product code: CCW Laryngoscope, Rigid
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Letters sent to customers/users to immediately discontinue use and quarantine any products with the affected product code and lot numbers and return them to the manufacturer.
Quantity in commerce: 338,928 (199,018 US and 139,910 OUS) for all products
Distribution: 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
Product codes and lots: Product Code 004551004; Lot Numbers 1812341, 1903341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1117-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)