State
73,584 recalls have nationwide distribution and so reach North Carolina. 10,299 additional recalls listed North Carolina specifically in their distribution scope.
Of the 10,299 recalls naming North Carolina we have scored against our rubric, 1,486 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,899 (28%) are Severe.
Which agencies issued them
These figures cover only the 10,299 recalls whose distribution notice names North Carolina specifically. The 73,584 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity, posing a risk of infection.
Medline Industries is recalling 459 units of Minor Pack convenience kits because open sterile seals may compromise sterility and lead to patient infection.
Medline is recalling 135 Open Heart A Pack kits in California due to a potential sterile barrier breach in the RCSP cannulae, posing a risk of infection.
Happiest Baby, Inc is recalling 1,055 units of SNOO Sleep Sacks because Extra Small and Extra Large sizes have not been reviewed for safety and effectiveness by the FDA.
Howmedica is recalling Triathlon hinge inserts made with aged polyethylene that may wear excessively, potentially causing device fracture or the need for revision surgery.
Nuclein LLC is recalling 182 DASH Rapid PCR Instruments due to a software issue. The recall affects units distributed in 18 US states.
GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
ICU Medical is recalling IV sets with drip chambers due to potential black specks and particulate matter in the fluid path.
Happiest Baby, Inc. is recalling SNOO Sleep Sacks because they have not been reviewed for safety and effectiveness by the FDA.
Mirion Technologies is recalling 783 Captus 4000e Thyroid Uptake Systems because a tension bolt may fail, causing the spring arm to fall unexpectedly.
ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.
Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles were inadvertently distributed as commercially marketed devices.
Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.
Bayer Medical Care is recalling 27,800 Stellant FLEX Syringe Kits because some may not have been properly sterilized due to a manufacturing issue.
GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.
Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.
Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.
GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.
ICU Medical is recalling IV sets with drip chambers because black specks may be present in the fluid path due to a plastic molding issue.
GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.
GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.