Home / Recalls / TELEFLEX LLC / Z-1010-2023

Z-1010-2023 Class II Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-1010-2023 was initiated by TELEFLEX LLC on Dec 8, 2022 and is designated Class II. Reason for recall: Potential for pilot balloon non-inflation or cuff non-deflation. The recall status is ongoing. Affected quantity: 2,270 units.

Recall Details

Product Type
Devices
Report Date
Feb 1, 2023
Initiation Date
Dec 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,270 units

Product Description

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation

Reason for Recall

Potential for pilot balloon non-inflation or cuff non-deflation.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.

Code Information

a. Product Code: 170060, Batch Number: KME21E1411, UDI: (01)04026704319558(17)260428(10)KME21E1411; b. Product Code: 170070, Batch Number (UDI): KME21D1430 ((01)04026704319572(17)260328(10)KME21D1430), KME21E1290 ((01)04026704319572(17)260428(10)KME21E1290); c. Product Code: 170075, Batch Number: KME21D1785, UDI:(01)04026704319589(17)260328(10)KME21D1785; d. Product Code: 170080, Batch Number (UDI): KME21D1204 ((01)04026704319596(17)260328(10)KME21D1204), KME21E1287 ((01)04026704319596(17)260428(10)KME21E1287); e. Product Code: 170085, Batch Number: KME21E1296, UDI:(01)4026704319602(17)260428(10)KME21E1296; f. Product Code: 170090, Batch Number: KME21E1232, UDI: (01)4026704319619(17)260428(10)KME21E1232

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1010-2023
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • Z-1947-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff… (May 25, 2023)
  • Z-1963-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF… (May 25, 2023)
  • Z-1962-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF… (May 25, 2023)
  • Z-1904-2023 Class I — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040 (May 25, 2023)
  • Z-1935-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040 (May 25, 2023)
  • Z-1849-2023 Class I — Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 (May 25, 2023)
  • Z-1841-2023 Class I — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 (May 25, 2023)
  • Z-1882-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF… (May 25, 2023)

FDA data resources