Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
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.
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.
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.
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.
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.
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 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.
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.
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.
WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.
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.
Airstream is recalling 2025 Classic travel trailers because a power hub may overheat, increasing the risk of a fire.
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials distributed nationwide.
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.
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.
MAMTAKIM Inc. is recalling ground cinnamon products distributed to nine states due to elevated lead content. The 15 g paper carton product carries code 10C035.
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.
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.
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 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.
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.
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.
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.
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.