FDAFDA · Food and drugs·Recall number Z-0396-2024
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Published November 29, 2023 · Recall initiated: September 27, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Poor image quality due to fluid ingress in the lens.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.
- Lot
- UDI-DI (GTIN): 08714729983514, Outer box UPN# M00542420, Lot / Batch # 31137538, 31537335, 31228699, 31590604, 31257049, 31635405, 31257050, 31683854, 31258726, 31802917, 31329914, 31810037, 31398618, 31991955, 31438355, 32006891, 31473069, 32146684. UDI-DI (GTIN): 08714729995746, Outer box UPN# M0054242CE0, Lot / Batch # 31199348, 31712358, 31574944.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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