State
72,820 recalls have nationwide distribution and so reach North Carolina. 10,258 additional recalls listed North Carolina specifically in their distribution scope.
Of the 10,258 recalls naming North Carolina we have scored against our rubric, 1,476 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,517 (25%) are Severe.
Which agencies issued them
These figures cover only the 10,258 recalls whose distribution notice names North Carolina specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.
PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.
Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seals, which could compromise sterility assurance during gynecological procedures.
Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.
ICU Medical is recalling specific lots of Hotline Fluid Warming Sets due to an increased likelihood of leakage from inadequate solvent application at the tubing to return connector bond.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.
Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Medtronic Neurosurgery is recalling Ventriculostomy Kit (REF: 46154) because endotoxin levels may exceed acceptable limits for devices contacting cerebrospinal fluid.
Alphatec Spine, Inc. is recalling the SafeOp Patient Interface due to a software issue that may cause loss of electromyography functionality during surgery.
SeaSpine Orthopedics Corporation is recalling SeaSpine Polyaxial Head (REF Number: 41-3010) because the component may pop off the screw during surgery.
Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.
FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.
Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.
AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.
Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.
Bionpharma Inc. is recalling Divalproex Sodium Delayed-Release Tablets, 500 mg, because some bottles may contain foreign tablets or capsules.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.