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.
Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.
Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.
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.
Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.
Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.
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.
Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.
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.
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.
Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.
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.
Shweetz Bakery-To-Go cookies are being recalled due to undeclared peanuts. The recall affects 11,070 cookies distributed across Pennsylvania, Maryland, Ohio, Virginia, and West Virginia.
B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.
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.
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.
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.
Universal Bakery Organic Sunrise Energy Bars labeled as gluten-free but found to contain gluten above FDA limits. The product poses a risk to consumers with celiac disease or gluten sensitivity.
B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.
Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.
Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.
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.
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 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.
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.