United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Sy...
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
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.
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY...
Incomplete seals on sterile product
Turtle Top - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWork...
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Diowave Laser System, REF: Diowave 250W
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF...
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.
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.
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Origi...
Foreign object (stainless steel dust/flakes or shreds of plastic)
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Med...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25...
Failed Dissolution Specifications
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ...
Out-of-specification endotoxin result that did not meet the acceptance criteria.
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOL...
Incomplete seals on sterile product
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
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.
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App...
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
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.
Swad Mango Flavored Masala Candy
Contains undeclared Blue 1
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
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.
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHE...
Incomplete seals on sterile product
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63...
Undeclared allergen ingredient (fish)