Boston Scientific EXALT D Duodenoscope: Poor Image Quality Due to Fluid Ingress
Boston Scientific recalls EXALT Model D Single-Use Duodenoscopes with specific outer box UPNs and lots due to poor image quality from fluid entering the lens.
Lower-risk recall
Poor image quality due to fluid ingress in the lens.
Contact the company
What happened, in plain English
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes that may have fluid entering the lens, causing poor image quality. This could lead to inaccurate medical procedures if used. Read more at govinfonow.com/recall/57220-boston-scientific-exalt-d-duodenoscope-poor-image-quality-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/57220-boston-scientific-exalt-d-duodenoscope-poor-image-quality-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0396-2024
Cite this page
“Boston Scientific EXALT D Duodenoscope: Poor Image Quality Due to Fluid Ingress.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57220-boston-scientific-exalt-d-duodenoscope-poor-image-quality-due-to. Based on FDA recall #Z-0396-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0396-2024%22&limit=1).
Why it’s dangerous
Fluid can enter the lens of the duodenoscope, causing poor image quality. This may result in inaccurate medical procedures if the device is used during endoscopic procedures.
Who’s affected
Patients and medical professionals who own or use the recalled EXALT Model D Single-Use Duodenoscopes with specific outer box UPNs and lots are affected. Medical staff using these devices during procedures are at the highest risk.
How to tell if you have this one
Check the outer box for UPN numbers M00542420 or M0054242CE0. Also look for specific lot numbers listed in the recall notice.
- Brand
Boston Scientific- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0396-2024 | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.; UDI-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. | US: 586 devices & OUS: 81 devices |
| Z-0397-2024 | EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.; 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, 31627631, 31193810, 31636279, 31232040, 31643793, 31239963, 31676406, 31248263, 31683921, 31251918, 31692257, 31269307, 31697145, 31275008, 31706116, 31283026, 31710191, 31305347, 31718478, 31322088, 31726052, 31334176, 31729292,31338402, 31734350, 31347461, 31738755, 31348990, 31738756, 31357937, 31754162, 31360721, 31762358, 31366683, 31764634, 31373783, 31767053, 31409362, 31774421, 31416272, 31783669, 31424741, 31826665, 31429697, 31828975, 31430274, 31846317, 31440192, 31858409, 31447120, 31874720, 31454624, 31915555, 31458181, 31939608, 31462880, 32033589, 31472232, 32047032, 31474875, 32082692, 31537336. UDI-DI (GTIN): 08714729995753, Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0, Lot /Batch # 31118201, 31331654 31129503, 31817723, 31265893. | US: 5,709 devices & OUS: 180 devices |
What to do — step by step
Check Device Details
Identify the outer box UPN number and lot numbers to confirm if your device is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
FDA distribution: “Worldwide - 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this device?
The recall states poor image quality, not a risk of serious injury. The danger level is low risk.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0396-2024 (September 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0396-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.