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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
510(K) Number: K193202
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Product Description
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FDA Recall
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EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-us... 2 05/13/2022 FEI # 3005099803
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-us... 2 05/13/2022 FEI # 3005099803
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use,... 2 05/13/2022 FEI # 3005099803
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use... 2 05/13/2022 FEI # 3005099803
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. 2 11/21/2023 FEI # 3005099803
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 &... 2 11/21/2023 FEI # 3005099803
Boston Scientific Corporation
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