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.
The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.
Greco Sidari is recalling Auricchio Crema al Reggiano cheese because the product was not held at appropriate temperatures, which could allow spoilage and pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.
Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.
Greco Sidari is recalling 1375 cases of Galbani Domestic Mascarpone due to improper storage temperature. The product was not held at appropriate temperatures, which could allow spoilage and support pathogen growth. Affected products were distributed in OH, NY, and PA between November 26, 2023, and January 5, 2024.
Saputo Stella cheese distributed in OH, NY, and PA from November 26, 2023 through January 5, 2024 has been recalled due to improper temperature storage. The temperature failure could lead to spoilage and pathogenic growth.
Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.
Sopra Ricotta Amalfi manufactured by Greco Sidari is recalled because the product was not held at appropriate temperatures. Improper storage could allow spoilage and pathogen growth.
Greco Sidari is recalling Grande Burrata cheese due to improper temperature storage that could support pathogen growth. The affected products were distributed across Ohio, New York, and Pennsylvania.
BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.
Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.
Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.
BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed diagnoses or inappropriate antibiotic selection.
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
Greco Sidari recalled 1,375 cases of Conway Caesar Empire Dressing due to improper temperature storage. The temperature control failure could affect food spoilage and potentially support pathogen growth.
BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.
Greco Sidari is recalling Ambriole Moliterno 7# wheel cheese due to improper temperature storage during distribution. The temperature conditions could allow spoilage and potentially support pathogen growth.
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.
GRANDE SOPRAFFINA ricotta cheese was not held at appropriate temperatures, potentially supporting pathogen growth. Affected lots distributed to OH, NY, and PA from November 26, 2023 to January 5, 2024.
Wegmans is recalling Ready To Bake Double Chocolate Croissants due to undeclared soy lecithin. The product may pose a serious risk to consumers with soy allergies.
A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.
A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.
Greco Sidari recalled fresh ciliegine mozzarella sold in Ohio, New York, and Pennsylvania due to improper temperature storage that could allow spoilage and potential pathogen growth.
Greco Sidari is recalling SOPRA Ricotta Amalfi sold in Ohio, New York, and Pennsylvania because the product was not held at appropriate temperatures, which could allow pathogen growth and spoilage.