State
72,984 recalls have nationwide distribution and so reach American Samoa. 25 additional recalls listed American Samoa specifically in their distribution scope.
Of the 25 recalls naming American Samoa we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.
Which agencies issued them
These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
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.
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.
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 certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
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.
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
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.
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.
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.
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.
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.
QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units 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.
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.