Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.
Philips X5-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
BD FACS 7-Color Setup Beads are being recalled because errors in the spectral overlap factors table may affect accurate setup of the flow cytometry instrument. 590 units affected.
Philips VL13-5 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.
Metoprolol Succinate Extended-Release Tablets 25 mg are being recalled because they failed dissolution acceptance criteria at the sixth month of long-term stability testing.
Gabapentin Capsules 100 mg from Major Pharmaceuticals are being recalled because of a defective container: the blister packaging was inadequately sealed. 3,527 bags are affected.
Philips L9-3 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Pitavastatin Tablets 1 mg from AvKARE are being recalled because they failed impurity and degradation specifications. 1,560 bottles are affected.
Philips X8-2t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips C5-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips V6-2 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips X6-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips X7-2t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.
Philips L12-3 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
Philips S7-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Pitavastatin Tablets 1 mg manufactured by Orient Pharma for Teva Pharmaceuticals are being recalled because they failed impurities and degradation specifications. 20,618 bottles affected.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Philips S8-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.