Edwards Lifesciences Recalls IV Administration Sets for Regulatory Submission
Edwards Lifesciences is recalling 147,350 units of IV Administration Sets because an additional FDA submission is required to support commercialization.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a regulatory documentation requirement (additional FDA submission) rather than a product defect or safety hazard, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Edwards Lifesciences, LLC is recalling 147,350 units of Intravascular (IV) Administration Sets. The affected models include 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, and MK2227.
The recall was initiated due to the requirement of an additional FDA submission to support the commercialization (clearance) of the devices. The source text does not indicate that this is a safety recall or that any adverse health consequences have been reported.
The distribution pattern is listed as US. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 147,350
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16