Becton, Dickinson and Company
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (4)
- EDWARDS LIFESCIENCES TECHNOLOGY SARL FEI 2648045 · PR
- BECTON, DICKINSON AND COMPANY FEI 3032916632 · CA
- CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG FEI 3003081151 · DO
- Edwards Lifesciences Holding B.V. FEI 3042941992 · NL
Recalls & enforcement
- Class IIOngoing2026-08-11Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
- Class IIOngoing2026-04-08Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Becton, Dickinson and Company — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10093301-becton-dickinson-and-company/
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