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.
Big Way Ca Inc is recalling Big Way Hot Pot Miso Paste because it contains undeclared milk from lactose.
Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.
Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
Theranica is recalling 11,886 Nerivio Infinity devices due to a potential battery thermal-runaway event during charging that may produce smoke and odor.
Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
Pack'n Fresh LLC is recalling various lots of Hondashi 0.25oz seasoning because the product contains fish that is not listed in the ingredients statement.
GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.
Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.
Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.
Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.
Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.
The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.