FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
- Recall number
- Z-0396-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
- Status
- Open, Classified
- Initiated
- 2023-09-27
- Posted
- 2023-11-21
- Terminated
- not on file
- Reason
- Poor image quality due to fluid ingress in the lens.
- Root cause
- Process control
- Action
- Notification of Urgent Medical Device Product Removal was issued via FedEx on Oct 3, 2023. The notice advises customers to immediately discontinue use and segregate affected product, and to complete and return the Reply Verification and Tracking Form (RVTF) even if you do not have any affected product. Customers are to post the notice near any affected product and notify end users. If further distributed, notify any customers to which product has been further distributed to. Reach out to your local Boston Scientific representative with any questions. The notice is batch / lot specific. Boston Scientific has implemented corrective changes and will make replacement EXALT Model D scopes available as soon as possible.
- Quantity
- US: 586 devices & OUS: 81 devices
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K193202"]
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28