Recall archive / FDA company announcement
BD Alaris: BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets — FDA announcement Sep 15, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Sep 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets
- Reason
- Pump performance variations compared to the performance described in the user manual could impact infusion delivery
- Classification
- Not supplied
- Recalling firm
- BD
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- fb29b4aff581fc6a
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 when used with a subset of compatible pump infusion sets, as compared to the performance described in the user manual. The update includes an expansion of 15 additional impacted pump infusion sets included in the recall, as well as new corrective actions and risk information. The 15 additional sets had been previously discontinued but may remain in inventory based on the expiration date. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The deviations in performance from the previously published ranges are attributable to these pump infusion sets' design features, such as filters and other in-line components. The products included in the recall were distributed nationwide in the United States, including Guam and Puerto Rico, and in Canada, Belgium and South Africa.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Sep 15, 2025
- Company announcement date
- Sep 12, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.