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.
Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient test results.
Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.
Arial Call Station wireless nurse call systems (models CSK200-1069 and CSK200-1069MR) are recalled due to risk of alarm communication failure and premature battery depletion. 77 units affected across multiple U.S. states.
Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.
Securitas Healthcare's Arial Call Station (models CSK200 and CSK200MR) may fail to transmit alarms and experience premature battery depletion. The FDA recall affects 1,268 units distributed in the U.S. and Canada.
Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.
B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.
B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.
Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.
Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.
Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.
Pacific Shellfish, Inc. is recalling Signature Blue Swimming Crab Claw and Lump canned crab (lots #78821 and #788454) from California due to storage at temperatures above 40°F without ice as of July 1, 2024.
Canadian Art Prints is recalling Indigenous Collection Signature Plates sets due to potential leachable lead exceeding FDA guidance levels. The affected sets were distributed across 18 US states.
The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.
Canadian Art Prints is recalling Indigenous Collection Signature Plates sets because the glazed ceramic plates may exceed FDA guidance levels for leachable lead. Consumers should stop using these plates immediately.
Sweet Preserved Dried Plums from Farmer's Grange contain undeclared cyclamate sweetener. The product was distributed in select U.S. states and should not be consumed.
Hemp Bombs CBD Pain Freeze is being recalled because the menthol content is weaker than the labeled 4% claim. The recall affects 2,082 bottles distributed nationwide.
Global Widget LLC is recalling Hemp Bombs CBD Pain Freeze (4% menthol) because the menthol concentration is below the labeled claim. Approximately 11,130 bottles were distributed nationwide.
Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.
Avanos Medical is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits because the Instructions for Use were missing required risk information about potential complications. No illnesses have been reported.
Hemp Bombs CBD Pain Freeze is being recalled because the menthol potency is less than the labeled 4%. Consumers should stop using the affected product and return it to the retailer.
Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.
FDA Class III recall of Nature's Script CBD Cryotherapy Pain Relief Roll-on (200mg, 1 oz bottles) due to subpotent menthol content less than the labeled 4%. The product did not contain the claimed amount of active ingredient.
Washington Homeopathic Products is recalling 11 Complete 30C/200C Homeopathic Kits nationwide due to a labeling error. Some bottles labeled as Ferrum Metallicum 200C actually contain Ferrum Phosphoricum 200C.
Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.