Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
CORFLO Safety PEG Kits, catalog number 30-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 31 kits are affected.
Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.
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.
MIC Safety PEG Kits, 20 Fr PUSH OTW, catalog number 7170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 901 kits affected.
Allia IGS 3 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. Nine units affected.
Bicarby Dialysate across six model numbers is being recalled because luer-lock leaks during preparation present a potential slip and fall hazard from fluid on the floor.
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.
Bicarby Dialysate, model RFP-400-G, is being recalled because of an error in the GTIN printed on the product, which could lead to a potassium concentration differing from the prescription.
TDC VELOCE 25G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
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.
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.
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.
Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 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.
Dragonfly Thai Ginger Powder, 4.37 oz, packed for U.S. Trading Company, is being recalled over potential contamination with lead. 1,800 units are affected.
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
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.
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.
CORFLO Safety PEG Kits, catalog number 30-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 61 kits are 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.
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.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 72 kits affected.
CORFLO Safety PEG Kits, catalog number 30-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 41 kits are affected.