Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits
Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source identifies this as an FDA Class II recall involving a sterile medical device with compromised packaging. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Edwards Lifesciences, LLC is recalling 597 units of the Sterile Oxymetry Oligon Catheter Kit (REF/UDI: XA3816SAFKT/ (01)00690103197181). The recall was initiated because the packaging for these devices was compromised.
The affected products are pressure injectable catheter kits. The specific lot codes involved in this recall are 62563142, 62157774, 62132722, 62749306, and 62625932. These units were distributed to facilities in Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Missouri, South Carolina, Tennessee, Texas, and Virginia.
Healthcare facilities and consumers should stop using the affected catheter kits and contact Edwards Lifesciences for further instructions or a replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheters
- Affected units
- 597
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model: XA3816SFKT LOT CODES: 62563142
- 62157774
- 62132722
- 62749306
- 62625932
Distribution
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
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII018A 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
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12