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.
Tobii Dynavox is recalling TD Navio Midi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Regeneron is recalling 21,353 vials of Libtayo (cemiplimab-rwlc) injection nationwide due to a lack of assurance of sterility.
American Regent, Inc. is recalling Aminocaproic Acid Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling Atropine Sulfate injection vials because they contain particulate matter, including hair, glass, and paraformaldehyde.
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
Grand Central Bakery is recalling specific potato sourdough bread products sold in Washington due to a potential foreign object hazard involving metal pieces.
Medtronic is recalling seven MiniMed 670G insulin pumps because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.
American Regent, Inc. is recalling Acetylcysteine Solution USP due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling Nitroglycerin injection vials due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.
Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.
Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.
Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
Philips is recalling 796 Cardiac Workstation 5000 units worldwide because they may intermittently provide inaccurate native heart rate data.
Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
Intersurgical Inc is recalling 1,575 One-Piece Guedel Airway devices because they could potentially be occluded or partially occluded.
Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.
Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.
Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.
Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.
Gifford's Dairy is recalling specific lots of HomeMaine Power Play Fudge ice cream due to potential rubber contamination.
restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.