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.
Philips Respironics is recalling DreamWear Full Face CPAP masks due to missing warnings about magnetic components that may pose risks to patients with implantable devices or metallic eye splinters.
Renaissance Food Group is recalling Small Medium Hatch Chile Pico de Gallo (9 oz units) because positive tests detected Listeria monocytogenes in the finished product. All products made with the same components are included in the recall.
Renaissance Food Group is recalling Medium Hatch Salsa (13 oz units) because positive test results detected Listeria monocytogenes in the finished product. The affected salsa was distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Vegetable Bowl products because testing found Listeria monocytogenes contamination. The products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling 12 oz packages of Snacking Peppers due to positive test results for Listeria monocytogenes. All products manufactured with the same components are affected.
Renaissance Food Group is recalling Asparagus Saute' products due to positive test results for Listeria monocytogenes. The recalled products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Fiesta Corn (10 oz) after positive test results confirmed Listeria monocytogenes in the finished product. All products made with the same components are affected.
Kenover Marketing Corp. is recalling Mighty Sesame Organic Tahini over potential Salmonella contamination. Approximately 13,766 units were distributed to stores across 20 states.
Renaissance Food Group is recalling Mild Guacamole Blender products due to positive test results for Listeria monocytogenes. The affected products were distributed in Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling 106 units of Seasoned Squash Onion & Dill due to detection of Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.
Antigua Farmacista Hand Sanitizer Ocean Citron (473 mL bottles) is being recalled because the product was found to contain benzene. The affected lot was distributed in Florida and Washington only.
Philips Respironics is recalling the Therapy Mask 3100 NC/SP because the product lacks warnings about magnetic components that may affect patients with implantable devices or metallic splinters in the eyes.
Renaissance Food Group is recalling Large Medium Salsa (13 oz) after positive test results for Listeria monocytogenes were detected in finished product. All products made with the same components are included in the recall.
Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.
Renaissance Food Group is recalling Hamburger Fixin's (10 oz units) distributed in Alabama, Georgia, and South Carolina due to positive test results for Listeria monocytogenes in the finished product.
Renaissance Food Group is recalling Tri-Pepper Blend (7 oz units) due to positive test results for Listeria monocytogenes. All products manufactured with the same components are included in the recall.
Renaissance Food Group is recalling Spicy Guacamole Blender products because positive test results confirmed Listeria monocytogenes contamination in the finished product.
Renaissance Food Group is recalling Hatch Chile Guacamole Blender due to positive test results for Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Renaissance Food Group is recalling Diced Red Onion (10 oz units) distributed to Alabama, Georgia, and South Carolina due to positive test results for Listeria monocytogenes in finished product.
Renaissance Food Group is recalling diced bell pepper and white onion products due to positive test results for L. monocytogenes. The recalled products were distributed in Alabama, Georgia, and South Carolina.
Cipla recalls Arformoterol Tartrate Inhalation Solution due to environmental monitoring failure affecting sterility assurance.
Eden's Answers Inc is recalling Sprigs Lil Ones Sleepy Time herbal supplement due to high bacterial growth in the product. Consumers should stop using it immediately.
IN MY BATHROOM LLC is recalling 485 units of the Seago SG-153 handheld UV-C germicidal wand nationwide due to excessive ultraviolet-C radiation. Consumers should stop using the device and contact the manufacturer for instructions.
Pfizer is recalling Aminophylline Injection vials due to a complaint of particulate matter (hair) in one vial. Over 103,000 vials were distributed to the US and Puerto Rico.