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.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/11 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 part 00055415005 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 15-2835/12 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 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.
CNC Noodle Corporation is recalling China Noodle Co. Steam Noodle packages due to undeclared wheat in the product, which poses a risk to consumers with wheat allergies.
Zydus Pharmaceuticals is recalling eight lots of Icosapent Ethyl Capsules 1 gram after red dots and melted capsules were found, caused by oxidation of the active ingredient.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8030/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/07 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo is recalled because the label lists semolina and durum flour as sub-ingredients but does not declare wheat. Consumers with wheat allergies or sensitivities may be at risk.
Coco's Italian Market Cannoli Making Kit is recalled because the label lists flour and ricotta cheese as sub-ingredients but fails to declare wheat and milk allergens. Consumers with wheat or milk allergies may be at risk if they consume the product.
Polski Ogrod Sp. z o.o. is recalling Hortex Mieszanka 9 Spring vegetable mix due to potential glass contamination. The affected product was distributed in Illinois.
Medline is recalling five surgical drape products because the fabric may delaminate prematurely when the included laundering instructions are followed.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
CNC Noodle Corporation is recalling ZHONG HUA CHAO MIAN fresh noodles due to undeclared wheat and Yellow #6 food coloring on the label. Consumers with wheat allergies or sensitivities to the colorant may be at risk.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/11 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 part 00055445008 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 00055360004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Raz Design is recalling several Mobile Shower Commode Chair models because a vendor modification means the seat may be reinstalled without properly engaging the outside rear seat brackets that hold it in place.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 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 00055360011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Willamette Valley Pie Company is recalling frozen raw blueberry crumble pies due to potential listeria monocytogenes contamination. The pies were distributed to grocery store in-store bakeries in Illinois and Oregon.
Lutronic is recalling the CLARITY II Laser System after reports of devices sparking or popping and potentially burning patients.
Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.
Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.