Boston Scientific Corporation: Medical Device Recall in 2023 - (Recall #: Z-0396-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Product Classification:

Class II

Date Initiated: September 27, 2023

Date Posted: November 29, 2023

Recall Number: Z-0396-2024

Event ID: 93281

Reason for Recall:

Poor image quality due to fluid ingress in the lens.

Status: Ongoing

Product Quantity: US: 586 devices & OUS: 81 devices

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated