State
72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
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.
NexxZr T Multi A3.5 zirconia discs for all-ceramic dental restorations are being recalled because a reduced or missing dentin layer increases the risk of fracture in the mouth.
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.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
MIC Safety PEG Kits, 14 Fr PUSH OTW, catalog number 7170-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 22 kits affected.
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.
MIC Safety PEG Kits with ENFit Connectors, 20 Fr PUSH OTW, catalog number 8170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Allia IGS 5 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. 121 units 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.
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.
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PUSH OTW, catalog number 8170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
Medartis APTUS 5.0 headed cannulated compression screws for bone fixation are being recalled because the cannulation of the screw is not centered. 13 units 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.
Duloxetine Delayed-Release Capsules, USP, 60 mg, are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit. 359,676 bottles affected.
Budesonide Inhalation Suspension, 1 mg/2 mL single-dose ampules from Sun Pharmaceutical, is being recalled after a quality complaint of black or brown specs and particles in the solution.
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.
Park St. Deli Macaroni & Cheese, 20 oz, is being recalled because of undeclared soy lecithin. The action covers 58,405 cases.
TDC VELOCE 23G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
MIC Safety PEG Kits with ENFit Connectors, 14 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues.
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.
Plum Solo 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.
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
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.