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.
Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.
RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental restorations to fracture in patients' mouths.
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
BF Suma Pharmaceuticals is recalling Longreen Corporation 4 in1 Cordyceps Coffee due to undeclared soy lecithin and coconut oil allergens. Affected products were distributed to California, Texas, Canada, and Guatemala.
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.
Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.
McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product was distributed to consumers in Arizona and Illinois.
RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.
Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.
Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.
Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.
The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.
Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.
Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.
RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.
Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.
RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.
McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product (UPC: 041500959030, July 23, 2025) was distributed in Arizona and Illinois.
Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.