State
72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
MIC Safety PEG Kits with ENFit Connectors, 20 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues. 6,005 kits affected.
Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.
SD LTM 64 PLUS EEG amplifier/recorders are being recalled because traces from different amplifiers in a multi-amplifier configuration may be displayed with a one-second shift.
Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
TDC VELOCE 27G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
Allia Moveo angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. Three units affected.
CORFLO Safety PEG Kits, catalog number 30-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 61 kits are affected.
Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.
MIC Safety PEG Kits, 14 Fr PULL, catalog number 7180-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 208 kits affected.
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PULL, catalog number 8180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 72 kits affected.
Halyard Drape Packs, kit code LMDP36-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 72 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 43 kits affected.
TDC VELOCE 25G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.
CORFLO Safety PEG Kits, catalog number 30-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 31 kits are affected.
Allia IGS 3 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. Nine units affected.
Merlin Patient Care System programmer software is being recalled because a malfunction during a pacing capture threshold test may stop the command to terminate the test being communicated.