News

Modern Healthcare6d
The companies with device recalls in Q1
Medline Industries led recalls in three categories, while Philips Medical Systems Nederland B.V. had the most devices ...
MassDevice10d
FDA says recall of Abbott HeartMate power unit is serious
This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...
USA Today18d
FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units ...
MedTech Dive6d
ICU Medical receives FDA warning letter over infusion pumps
Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.
FDA warning hits Minnesota-made infusion pumps for missing regulatory checks
Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...
American Hospital Association11d
Recall issued for aspiration system by Q’Apel Medical
The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company ...
MassDevice15d
FDA says Q’Apel aspiration system recall is Class I following discontinuation
Q’Apel Medical announced that the FDA classified a voluntary recall of its 072 A System as Class I, the most serious kind.
Morningstar18d
FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
The recall was initiated because the company ... Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment ...