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.
Butternut squash cubes sold in Kentucky, Michigan, Ohio, and West Virginia are recalled due to potential Listeria monocytogenes contamination. Affected products have sell-by dates between July 9 and July 26, 2024.
Unilever North America is recalling Popsicle Jolly Rancher Frozen Confection Pops nationwide due to undeclared milk, which poses a risk to consumers with milk allergies.
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
Reser's Fine Foods recalls 6 cases of Item 71117.03034 Banana Pudding Kit due to temperature abuse from a malfunctioning refrigeration unit. Affected products were distributed to CA, IL, MN, ND, and SD.
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials distributed nationwide.
Reser's Fine Foods is recalling Reser's American Classics Scalloped Potatoes because a refrigeration unit malfunction caused temperature abuse during shipment, potentially leading to spoilage. Consumers should not consume this product.
Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.
WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.
Pita Jungle Hummus & Pita Chips snack packs are being recalled because the product label fails to declare sesame, an ingredient in the hummus. Consumers with sesame allergies may face health risks.
Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.
ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.
ProRx LLC is recalling Tirzepatide 20 mg/2mL injectable vials nationwide due to lack of assurance of sterility. Patients who received vials from lot ProRx051424 should contact their healthcare provider.
ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Reser's Fine Foods is recalling 7 cases of Smokehouse Potato Salad due to potential spoilage from temperature abuse during shipping. No illnesses have been reported.
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.
Reser's Fine Foods recalls Item 71117.14459 Gravy Homestyle due to temperature abuse during shipping. The product may become spoiled and pose food safety risks.
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
SSP America PHX, LLC is recalling Almond Croissants sold in Arizona. The product label states 'almond' in the product name but fails to declare tree nuts in the ingredients or allergen statement, risking allergic reactions.
Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.