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.
What this means for you
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
- 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.
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