FDA recall Z-2589-2023

Product

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Reason for recall

Flexible intubation endoscopes sterility assurance can not be confirmed.

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2023-07-07

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2023