State
73,092 recalls have nationwide distribution and so reach Hawaii. 2,770 additional recalls listed Hawaii specifically in their distribution scope.
Of the 2,770 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 569 (21%) are Severe.
Which agencies issued them
These figures cover only the 2,770 recalls whose distribution notice names Hawaii specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
NQDTPBOR multi-purpose helmets for teens do not comply with federal bicycle safety standards for impact protection, stability, labeling, and certification. The recalled helmets, sold on Amazon from May to August 2024, can fail to protect wearers in a crash.
GiantMouse is recalling about 600 GM12 and GMP12 folding knives because the locking mechanism can fail during use, creating a laceration hazard. No injuries have been reported.
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.
Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.
Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.
Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.
Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.