RUSCH recallZ-1294-2021 · Teleflex Medical Inc · initiated Feb 18, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
The US consignee notification letter "Urgent Medical Device Recall Notification" and Recall Acknowledgement form sent on 02/18/2021 via FedEx 2-day mail.
Recall details
- Recall number
- Z-1294-2021
- Status
- Terminated
- Initiated by the company
- Feb 18, 2021
- Recalling firm
- Teleflex Medical Inc
- Quantity
- 157, 150 units (156,980 units in the US; 170 units OUS)
- Product code
- CCW
- 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 description
RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Code information (models, lots, serial numbers)
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).
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- RUSCH IPN039529Teleflex Incorporated · LARYNGOSCOPE, RIGID1 recall0 reports
- RUSCH IPN039530Teleflex Incorporated · LARYNGOSCOPE, RIGID1 recall0 reports
- RUSCH IPN039531Teleflex Incorporated · LARYNGOSCOPE, RIGID1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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