Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.
Philips Ultrasound is recalling 5,230 L8-4 transducer units that were refurbished beyond their useful life, which may affect device safety and performance. The units were distributed nationwide and internationally.
Geneoscopy, Inc. is recalling ColoSense Test Kit Part No. 80-001 (Lot 80-001-A2501) due to multiple plate failures caused by Low Positive Template Control being too high and out of range.
Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.
Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices that were refurbished beyond their useful life. The affected devices have been distributed domestically and internationally.
Philips Ultrasound is recalling approximately 5,230 eL18-4 EMT ultrasound transducers that were refurbished beyond their useful life, which may affect device performance or safety.
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.