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.
Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are affected.
Vasopressin 2 Units/2 mL in 0.9% sodium chloride syringes from IntegraDose Compounding Services are being recalled as a subpotent drug. 287 units are affected.
Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.
Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
ConMed AirSeal 12 mm Access Ports with Low Profile Bladeless Optical Tip Obturators are being recalled because of the potential for overpressure alerts. 71,151 packs affected.
ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.
Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.
Giraffe OmniBed Carestations are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 23,430 units affected.
Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.
Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.
Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.
Medline CATH 22F Robinson sterile 5-packs are being recalled because representative samples did not meet applicable catheter performance specifications. 1,000 units are affected.
ConMed AirSeal 5 mm Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.
Medline Laparoscopy Combined - No Ndl procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 72 units affected.
Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.
ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.
Medline C-Section Kits and Packs are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline C-section kits, packs and recovery kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
The Medline Add-A-Cath Arterial Insertion kit and Ped School Age PICC Dressing Tray are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
PureLife Topical Anesthetic Gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 450 units are affected.
Circle K Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,420 tubes are affected.
Safco SensiCaine-Ultra Topical Anesthetic Gel, 20% benzocaine strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units affected.