CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed recalled by Covidien

Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed, distributed in 25 states. The recall was initiated on 10 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX

Quantity recalled12,310 devices

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-1318-2023
FDA event ID: 91841
Recalling firm: Covidien, Boulder, CO
Classification: Class II
Status: Ongoing
Recall initiated: 10 Feb 2023
FDA classified: 31 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

10 Feb 2023	Recall initiated by company
31 Mar 2023	Classified by FDA	+49 days
5 Apr 2023	Published in enforcement report	+5 days

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

Reason for recall

Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.

Where it was distributed

U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada

Alaska Arizona California Florida Georgia Iowa Illinois Indiana Kansas Maryland Michigan Mississippi North Carolina Nebraska New Jersey New York Ohio Oklahoma Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

Which lots are affected?

Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX

Where was it sold?

U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada

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.

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