Recall archive / FDA device enforcement
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tu... — FDA record Z-1318-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
- Classification
- Class II
- Recalling firm
- Covidien
- Quantity
- 12,310 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1318-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Feb 10, 2023
- Center classification date
- Mar 31, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.