State
72,940 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.
Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.
Which agencies issued them
These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
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.
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.
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.
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.
BulkSupplements.com Inositol powder, lot 2507803, is recalled because the finished product may be contaminated with pathogenic Staphylococcus aureus. 1,001 units 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.
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.
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.
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.
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.
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.
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.
SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.
Fagron Sterile Services bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL single-dose syringes, is recalled nationwide for lack of assurance of sterility. 109,320 syringes 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 GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units 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.
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.
Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles 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.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 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.
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.
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.