United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS...
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258...
Potential for mislabeled syringe produced by the i.v.STATION device.
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, ...
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOL...
Incomplete seals on sterile product
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UD...
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
Blue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravasc...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravasc...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-...
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ...
Due to nonconforming products being inadvertently distributed.
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Pure Ground Ingredients-Organic Peppermint Leaf Powder. wholesale bulk; tea/food...
Product has the potential to be contaminated with Salmonella.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-30...
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Wabash National Corporation - Missing Conspicuity Tape/FMVSS 108
Missing conspicuity tape can reduce the visibility of the trailer to other drivers, increasing the risk of a crash.
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-...
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
K.Z., Inc. - Incorrectly Tightened Shock Bolts
Broken shock retainer bolt heads and washers may detach and become a road hazard for other vehicles, increasing the risk of a crash.