State
72,992 recalls have nationwide distribution and so reach Hawaii. 2,767 additional recalls listed Hawaii specifically in their distribution scope.
Of the 2,767 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 2,767 recalls whose distribution notice names Hawaii specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.