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.
Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Willamette Valley Pie Company is recalling Frozen Raw Bulk 9 inch Blueberry Crumble Pie due to potential contamination with listeria monocytogenes. The frozen pies were sold to grocery retailers' in-store bakeries in Illinois and Oregon.
International Life Sciences is recalling the Artelon FlexBand Dynamic Matrix, ref 31057, because the augmentation devices failed bacterial endotoxin testing.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2836/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
International Life Sciences is recalling Artelon FlexBand Plus, refs 41054 and 41057, because the augmentation devices failed bacterial endotoxin testing.
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Physio-Control is recalling Infant/Child Reduced Energy Defibrillator Electrodes, catalogue numbers 11101-000016 and 11101-000017, due to pediatric defibrillator electrode delamination.
Medline is recalling Medcrest surgical gowns because the fabric may delaminate prematurely when the included laundering instructions are followed.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/09 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Boston Scientific is recalling EndoVive Safety PEG Kits containing BD ChloraPrep Triple Swabsticks because open or compromised seals on the swabstick packaging could cause loss of sterility.
International Life Sciences is recalling the Artelon FlexBand Twist .12, ref TW012, because the augmentation devices failed bacterial endotoxin testing.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Exactech is recalling the Equinoxe Core Instrument Kit, model KIT-311X, because the impactor handle may be missing a cross-pin.
Covidien is recalling the HealthCast Vital Sync Remote Patient Monitoring System after complaints that alarms from the primary patient bedside monitor were not transmitted to or received by the remote system.