State
72,940 recalls have nationwide distribution and so reach South Carolina. 7,116 additional recalls listed South Carolina specifically in their distribution scope.
Of the 7,116 recalls naming South Carolina we have scored against our rubric, 1,268 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,870 (26%) are Severe.
Which agencies issued them
These figures cover only the 7,116 recalls whose distribution notice names South Carolina specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
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.
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.
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.
Zydus Entecavir Tablets, USP, 1 mg, lot E309377, are recalled nationwide after failing impurity and degradation specifications. 4,440 bottles are affected.
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, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.
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.
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.
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.
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.
B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags 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.
Frozen AquaStar Breaded Butterfly Shrimp, clean-tail, in 3 lb packages is recalled because the product may be contaminated with Cesium-137. 126 cases are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.
Zydus Entecavir Tablets, USP, 0.5 mg, lot E309376, are recalled nationwide after failing impurity and degradation specifications. 4,344 bottles are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
Hi-Tech Pharmaceuticals Joint-RX dietary supplement, 90 count, lot 503110607, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
iForce Nutrition Joint Help dietary supplement, 120 capsules, lot 101330812, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.
LG Sciences Battle Hardener Platinum Series complete 6 week cycle with PCT 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.
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 EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.