State
72,936 recalls have nationwide distribution and so reach Hawaii. 2,766 additional recalls listed Hawaii specifically in their distribution scope.
Of the 2,766 recalls naming Hawaii we have scored against our rubric, 333 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 567 (20%) are Severe.
Which agencies issued them
These figures cover only the 2,766 recalls whose distribution notice names Hawaii specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.
Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
Fujirebio Diagnostics is recalling 128 units of Lumipulse G beta-Amyloid 1-42-N Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo Protein Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Diva Fam is recalling Sea Moss Gel Superfood in the Wildcrafted variety over potential Clostridium botulinum contamination.
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.
Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC412Q-0215, because devices which did not undergo thermoforming could deform and lose performance.
Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0330, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Vantive US Healthcare is recalling 264,040 units of the PRISMAFLEX ST150 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Fazt & Loud is recalling Lost and Found Energy, Sour Gummy Bear, because a label misprint states 150mg of caffeine when the product contains 300mg.
Siemens is removing three software applications from 88 NAEOTOM Alpha CT systems because the applications have not received FDA 510(k) clearance.
Optiwize is recalling 78 units of OptiWize Collagen Plus, 320 count, after NSF testing showed the manganese level was below the label quantity.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could deform and lose performance.