Drug recall
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box…
FDA recall event 93281 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 93281 |
|---|---|
| Recall numbers | Z-0396-2024, Z-0397-2024 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0., EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Poor image quality due to fluid ingress in the lens. |
| Initiation date | Sep 27, 2023 |
| Report date | Nov 29, 2023 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: