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.
Alpha Plant-Based Burrito products contain undeclared milk that poses an allergen risk. THE MISO BROTHERS INC is recalling 31,092 units distributed throughout US retail locations.
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.
Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.
Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.
The Miso Brothers is recalling Alpha Plant Based Breakfast Burritos because they contain undeclared milk. This poses a risk to consumers with milk allergies or sensitivities.
THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito - CHIK'N FAJTA frozen breakfast burritos because they contain undeclared milk that is not listed on the label. The product poses a risk to consumers with milk allergies.
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.
Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.
Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
THE MISO BROTHERS INC is recalling Alpha Plant-Based Burritos because they contain undeclared milk, a common allergen. Approximately 31,092 units are affected across US retail locations.
Joy Joys Bakery LLC recalls Ube Spanish Bread because the label lists 'flour' without specifying it is wheat flour, failing to disclose a major allergen. The product was distributed in Washington and Oregon.
THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito (Pizza, 5.5 oz) because the product contains undeclared milk. Consumers with milk allergies should not consume this product.
The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.
THE MISO BROTHERS INC is recalling Alpha Plant-Based Breakfast Sandwiches because they contain milk that is not listed on the label. Consumers with milk allergies may experience allergic reactions.
Joy Joys Bakery is recalling Ube Roll packages because the label lists 'flour' but does not specify it is wheat flour, creating an allergen risk for consumers with wheat sensitivity.
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
DR SNACK Crystal Ginger was recalled because the product contains undeclared sulfites. Affected products were distributed in the Northeast U.S.
Organic jackfruit produced by Food Castle, Inc. is being recalled due to undeclared sulfites not listed on the product label. Sulfite-sensitive consumers face potential allergic reaction risk.
MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
Joy Joys Bakery LLC is recalling Ube Ensaymada sold in Washington and Oregon due to undeclared wheat. The product label lists flour but does not specify wheat flour.
Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer due to manufacturing practice deviations. The recall affects 124 bottles with lot number C013121 distributed in Puerto Rico.
CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.