State
72,919 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 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
Merit Medical is recalling ProGuide Chronic Dialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Isuzu is recalling 2025-2027 commercial trucks because wire harnesses may chafe, causing engine stalls, brake failures, or fires.
Navajo Manufacturing is recalling the Handy Solutions Neck & Shoulders Heating Pad because folding it during use raises power density in the folded area, causing excessive temperatures the limit device cannot sense.
Olympus is recalling the OER-Elite Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.
I.T.S. GmbH is recalling the HLS Hand Locking Plates System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
I.T.S. GmbH is recalling the Distal Ulna Locking and Ulna Osteotomy Locking Systems because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
I.T.S. GmbH is recalling Straight Plates with Angular Stability, including forearm and compression plates, because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
I.T.S. GmbH is recalling Pilon Plates with Angular Stability and Anterolateral Tibia Plates because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
Olympus is recalling PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.
Chiesi USA is recalling three lots of Curosurf (poractant alfa) Intratracheal Suspension for lack of assurance of sterility.
Teva is recalling nine lots of Octreotide Acetate for Injectable Suspension 20 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Olympus is recalling the MAJ-1444 Endoscope Air/Water Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
I.T.S. GmbH is recalling the HCS Headless Compression Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.
I.T.S. GmbH is recalling the Pelvic Reconstruction System fixation screw and short spike because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
GE Medical Systems is recalling the Imactis CT-Navigation System because of a potential discordance between the simulated needle trajectory and tip position and the actual trajectory and tip position.