Boston Scientific Corporation: Medical Device Recall in 2023 - (Recall #: Z-0397-2024)

EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.

Class II

Poor image quality due to fluid ingress in the lens.

UDI-DI (GTIN): 08714729993605, Outer box UPN# M00542421, Inner box UPN # M00542420, Lot / Batch # 31118200, 31537337, 31118202, 31538040, 31129470, 31544823, 31145980, 31544825, 31150536, 31590918, 31150537, 31591865, 31150538, 31607291, 31175587, 31619981, 31193809, 31627631, 31193810, 31636279, 31232040, 31643793, 31239963, 31676406, 31248263, 31683921, 31251918, 31692257, 31269307, 31697145, 31275008, 31706116, 31283026, 31710191, 31305347, 31718478, 31322088, 31726052, 31334176, 31729292,31338402, 31734350, 31347461, 31738755, 31348990, 31738756, 31357937, 31754162, 31360721, 31762358, 31366683, 31764634, 31373783, 31767053, 31409362, 31774421, 31416272, 31783669, 31424741, 31826665, 31429697, 31828975, 31430274, 31846317, 31440192, 31858409, 31447120, 31874720, 31454624, 31915555, 31458181, 31939608, 31462880, 32033589, 31472232, 32047032, 31474875, 32082692, 31537336. UDI-DI (GTIN): 08714729995753, Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0, Lot /Batch # 31118201, 31331654 31129503, 31817723, 31265893.

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: Firm initiated