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 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.
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.
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.
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.
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.
WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.
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.
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
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.
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.
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.
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.
Reser's Fine Foods is recalling 182 cases of Potatoes Creamy Deluxe Special Request due to temperature abuse that may cause food spoilage.
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.
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.
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.
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.
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 recalls Pita Jungle Cilantro Jalapeno Hummus & Pita Chips snack packs due to undeclared sesame allergen on the label. Consumers with sesame allergy risk serious allergic reactions.
ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL nationwide due to lack of assurance of sterility. Affected lots have beyond-use dates of 11/21/2024 and 12/09/2024.
Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.
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.