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Boston Scientific Corporation Recall 93281

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

Boston Scientific Corporation Recall 93281 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0396-2024
Event ID93281
Event DescriptionEXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Product TypeDevices
DistributionWorldwide - 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.
QuantityUS: 586 devices & OUS: 81 devices
Recall ReasonPoor image quality due to fluid ingress in the lens.
Device Classification20231129
Device Code InfoUDI-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.
Center Classification Date20231121
Recall Initiation Date20230927
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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