Agency classClass IIOur severity:High FDA (Devices)·Z-0397-2024·Announced 2023-11-29

EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress

Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall affecting a risk-of-harm medical device used in diagnostic procedures. The fluid ingress defect compromises image quality during clinical use. However, the source text reports no hospitalizations, injuries, or adverse events, which limits the score to High (3) per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling EXALT Model D Single-Use Duodenoscopes in 2-pack configurations. The affected devices are identified by UPN numbers M00542421 (outer box) with M00542420 (inner box), or M0054242CE1 (outer box) with M0054242CE0 (inner box).

The duodenoscopes are being recalled due to fluid ingress in the lens assembly, which causes poor image quality during use.

The recall affects approximately 5,709 devices in the United States and 180 devices internationally. US distribution includes all states. International distribution includes countries in Europe, Oceania, and North America. Specific lot numbers ranging from 31118200 to 32082692 have been identified.

Healthcare facilities should immediately discontinue use of affected devices and verify their inventory using the provided lot numbers and UPN identifiers. Contact Boston Scientific for replacement, repair, or return instructions.

The recalled product

Product: EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Diagnostic Endoscopy
Hazard: fluid-ingress
image-quality

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · fluid ingress