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 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.
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.
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.
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.
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.
The BD Pyxis QFill Replenishment Station medication cabinet has a software issue that may print incorrect bin information on restock labels for medications stored in non-CUBIE locations.
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.
SSP America PHX, LLC recalls Pita Jungle Greek Salad (11.8oz clamshell) because the product label listed feta but failed to declare milk as an allergen. Consumers with milk allergies should not consume this product.
SSP America PHX, LLC is recalling Cheese Danish pastries distributed in Arizona. The product labels list cheese but fail to declare milk in the allergen statement, posing a risk to consumers with milk allergies.
Multiple apple juice brands sold nationwide are being recalled due to inorganic arsenic levels above FDA action thresholds. The recall affects approximately 141,298 cases sold by Refresco Beverages US Inc.
Reser's Fine Foods recalls 18 cases of Raspberry Parfait Desserts due to temperature abuse during transport that may have caused spoilage. Products with use-by date 12/4/2024 distributed in CA, IL, MN, ND, and SD.
SSP America PHX is recalling Apple Danish products due to incorrect ingredient labeling. The label lists Almond Croissant ingredients instead of Apple Danish, creating a risk for consumers with tree nut allergies.
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials 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.
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.
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.
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.
W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Reser's recalls 104 cases of sweet corn with butter due to shipment temperature abuse that may cause spoilage. Use By date Sept. 9, 2024; distributed in CA, IL, MN, ND, and SD.