State
72,969 recalls have nationwide distribution and so reach North Carolina. 10,261 additional recalls listed North Carolina specifically in their distribution scope.
Of the 10,261 recalls naming North Carolina we have scored against our rubric, 1,476 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,520 (25%) are Severe.
Which agencies issued them
These figures cover only the 10,261 recalls whose distribution notice names North Carolina specifically. The 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
B. Braun Sterile Water for Injection USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 26,316 bags are affected.
Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.
Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.
Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.
UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Charge-Up Chilaquiles, 3.5 oz, lot 52061, is recalled because Yellow #5 and Yellow #6 are undeclared. 566 packages are affected.
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.
Zydus Entecavir Tablets, USP, 1 mg, lot E309377, are recalled nationwide after failing impurity and degradation specifications. 4,440 bottles are affected.
UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Campsite Lentejas, 4.0 oz, lot 52060, is recalled because Yellow #5 and Yellow #6 are undeclared. 154 packages are affected.
The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.
UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
PrimeNutrition Phytoform Fruits & Greens Formula in watermelon, 13.75 oz, lot 174271126, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.
PrimeNutrition Taurine, 8.12 oz, lot 710581618, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Hi-Tech Pharmaceuticals Fish Oil, 90 soft gels, lot 517120551, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg double strength, in 6, 10, 14 and 20-count bottles are recalled because a micro-organism was found on a lot of packaging coil.
Formutech Nutrition Flexible Joint Formula with Cissus Quadrangularis, 240 capsules, lot 405310805, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.