Use cautionMedical device recall · FDA · Published February 18, 2021
Teleflex Polaris Laryngoscope Recall: Cracks at Hinge Risk
Teleflex recalls Polaris laryngoscopes with cracks or breaks at the hinge due to customer reports. Models 44401-44403 with specific lots are affected. Stop using if you have these items.
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
“Teleflex Polaris Laryngoscope Recall: Cracks at Hinge Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63259-teleflex-polaris-laryngoscope-recall-cracks-at-hinge-risk. Based on FDA recall #Z-1294-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1294-2021%22&limit=1).
The FDA announced on Feb. 18, 2021, that Teleflex Medical Inc. is voluntarily recalling Rusch Polaris laryngoscopes because handles may crack or break at the hinge. The agency issued recall number Z-1294-2021 for the Class II device.
Teleflex is recalling the products due to customer reports that the laryngoscope handles develop cracks and/or break at the hinge. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Teleflex Medical Inc. has 11 other recalls on record since Oct. 11, 2019. Other recent recalls of similar products include Draeger ErgoStar CM 60 Airway Connector Recall (Nov. 10, 2025) and Canon Alphenix X-ray Systems Recall (Aug. 4, 2026).
How to tell if you have this one
Check for Polaris laryngoscopes with model numbers 44401, 44402, or 44403. The specific lots (197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T) are also affected.
Brand
Teleflex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Cracks
Inspect the hinge area for cracks or breaks in the laryngoscope handle.
Stop Using if Cracked
If you find cracks or breaks at the hinge, stop using the laryngoscope immediately.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1294-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1294-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.