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.
Karabetian Import and Distribution is recalling Zimi Puff Pastry French Style over partially hydrogenated oils in foods exported to the US.
A New Life Herbs is recalling 23 bottles of Baby Allergy Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Karabetian Import and Distribution is recalling Zimi Kunefe Ready to Eat over partially hydrogenated oils in foods exported to the US.
A New Life Herbs is recalling 48 bags of Organic Ginger Root Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
A New Life Herbs is recalling 22 bottles of Ear Drops Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Lexunder is recalling 701 units of Food to Live brand Organic Moringa Leaf Powder contaminated with Salmonella. The FDA has classified the action as Class I.
Lexunder is recalling 159 units of Food to Live brand Organic Supergreens Powder Mix contaminated with Salmonella. The FDA has classified the action as Class I.
GE Medical Systems is recalling 1,277 Carestation anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The FDA has classified the action as Class I.
MAMTAKIM is recalling 45 cases of Belevini Korushka dried salted whole smelts over Clostridium botulinum in uneviscerated fish. The FDA has classified the action as Class I.
MAMTAKIM is recalling 4 cases of Belevini Bichki dried salted whole smelts over Clostridium botulinum in uneviscerated fish. The FDA has classified the action as Class I.
GE Medical Systems is recalling 203 Carestation anesthesia system Power Management Board field replaceable units over potential unexpected shutdown if AC mains power is lost.
Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.
GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.
The Whole Herb Company is recalling 3,580 lbs of organic cut and sifted senna leaves over potential Salmonella contamination. The FDA has classified the action as Class I.
The New York Milk Bank is recalling 66 bottles of pasteurized donor human milk over a foreign object.
Cepheid is recalling 6,325 Xpert BCR-ABL Ultra kits, catalog GXBCRABL-US-10, because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.
Good Way Trading Group is recalling 150 bags of BaiLiFeng Dried Cinnamon Powder that contains high levels of lead, measured at 10.7 mg/kg.
Mindray is recalling 906 BeneVision Distributed Monitoring System units because a specific workstation hardware configuration may experience audio playback failure or screen freezing.
Rocket Medical is recalling 630 Rocket 18Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.
Rocket Medical is recalling 246 Rocket 20Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.
AVID Medical is recalling 90 Halyard Major Packs over the potential for an incomplete seal on the header bag.
PATH is recalling MADSEN AccuScreen probes because distortions after a speaker replacement can mimic true DPOAE responses and may result in a false PASS outcome.
Fresenius Medical Care is recalling 115 5008X CAREsystem units over several software anomalies with the potential to impact patient treatment, one of which may result in treatment stop.