Reported Nov 29, 2023 · Ongoing
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- EXALT Model D Single-Use DuodenoscopeOuter box UPN# M00542420 & Outer box UPN# M0054242CE0
- Lot codes and dates
- UDI-DI (GTIN)
08714729983514Outer box UPN# M00542420Lot / Batch # 311375383153733531228699315906043125704931635405312570503168385431258726318029173132991431810037313986183199195531438355320068913147306932146684
- UDI-DI (GTIN)
08714729995746Outer box UPN# M0054242CE0Lot / Batch # 311993483171235831574944
- UDI-DI (GTIN)
- Amount recalled
- US: 586 devices & OUS: 81 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Poor image quality due to fluid ingress in the lens.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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