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All product recalls associated with Mindray DS USA, Inc., dba Datascope Patient Monitoring.
Total Recalls
1000
Past Year
100
Class I (Serious)
84
Most Recent
Dec 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.
The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias. Because of these findings, a new Total Bilirubin calibrator value assignm