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.
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.
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.
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.
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.
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.
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.
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 is recalling Stonemill Kitchens Green Goddess Pasta Salad due to potential spoilage from temperature abuse caused by a malfunctioning refrigeration unit. The product was distributed in CA, IL, MN, ND, and SD.
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.
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.
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.
Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.
Reser's Essential Everyday Original Potato Salad recalled due to potential spoilage from temperature abuse affecting refrigerated units. Affected cases distributed in CA, IL, MN, ND, and SD.
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.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Reser's American Classics Macaroni & Cheese (12 oz) is recalled because a malfunctioning refrigeration unit caused temperature abuse during shipment, which may cause spoilage.
Reser's Fine Foods recalls Baked Scalloped Potatoes due to potential spoilage from temperature abuse during shipment. Affected products have Use By dates of September 11–13, 2024.
Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.
Reser's American Classics Egg Salad has been recalled due to potential spoilage caused by temperature abuse from a malfunctioning refrigeration unit. The affected product was distributed in five states.
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
Reser's Fine Foods recalls Asiago Creamed Spinach due to potential spoilage from temperature abuse during transport. The affected product has a use-by date of August 31, 2024.