Z-1294-2021Class II

RUSCH POLARIS" Laryngoscope -

Name: Z-1294-2021 RUSCH POLARIS" Laryngoscope -
Creator: Teleflex Medical Inc
Published: 2021-02-18
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2021-02-18 / Open, Classified

FDA source

TELEFLEX MEDICAL INC began a recall of RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation on 2021-02-18. FDA classified it as Class II and gives the reason as "Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1294-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-18
Posted: 2021-03-23
Recalling firm: Teleflex Medical
Product: RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
FDA root cause: Under Investigation by firm
Action: The US consignee notification letter "Urgent Medical Device Recall Notification" and Recall Acknowledgement form sent on 02/18/2021 via FedEx 2-day mail.
Quantity in commerce: 157, 150 units (156,980 units in the US; 170 units OUS)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.
Product codes and lots: Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-31	2021-03-23

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)