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.
Pocas International Corp. is recalling Popping Boba RTD Mango Passion Fruit Green Tea due to a packaging integrity issue that may compromise product quality.
Pocas International Corp. is recalling Popping Boba RTD Peach Oolong Tea due to a packaging integrity issue that may compromise product quality.
Pocas International Corp. is recalling Popping Boba RTD Strawberry Dragon Fruit Oolong Tea due to a packaging integrity issue that may compromise product quality.
Super World Trading Inc. is recalling Mei Heong Yuen Walnut Flavor Roasted Peanuts (9.17 oz) because the product contains cyclamates, a sweetener banned in the United States.
Pocas International Corp. is recalling Popping Boba RTD Mixed Berry Hibiscus Tea due to a packaging integrity issue that may compromise product quality.
CentrosFLO Hemodialysis Catheters are recalled due to a design defect that may prevent proper splitting of the sheath, risking hemorrhage, blood clots, and other serious complications.
Merit Medical Systems is recalling the BioFlo DuraMax Catheter due to a design defect that prevents proper splitting, which may result in hemorrhage, thrombosis, and other serious complications.
Erbe USA Inc is recalling 3,603 flexible cryoprobes (REF: 20402-411) nationwide. The devices may rupture during use, posing patient safety risks.
Philips Respironics Trilogy EV300 ventilators may deliver an incorrect amount of air when used with non-pneumatic nebulizers, potentially affecting respiratory support in dependent patients.
Ajinomoto Foods North America is recalling Teppanyaki Style Vegetable Fried Rice due to the presence of glass fragments ranging from 1–3 cm long. Consumers should not eat affected products and should discard or return them.
Handy Solutions Neck & Shoulders Heating Pad (Model 25607) recalled nationwide. Device may overheat if folded or placed under body, causing burning smell, material damage, and potential burns to users.
Philips Respironics Trilogy Evo O2 ventilators may not deliver the correct breathing support when used with non-pneumatic nebulizers. Verify nebulizer compatibility and contact Philips for guidance.
Bakkavor is recalling Basil Pesto & Mozzarella Pizza due to metal fragments discovered in the product. The contamination originated from roasted tomatoes supplied by an ingredient supplier.
Philips Respironics Trilogy Evo Universal ventilators may have tidal volume discrepancies when used with non-pneumatic nebulizers. Approximately 113,717 units distributed worldwide are affected by this Class I recall.
Erbe USA Inc is recalling 64,216 Flexible Cryoprobes used in surgery because they may rupture or burst during activation. Affected units were distributed nationwide.
Philips Respironics Trilogy Evo ventilators may deliver incorrect tidal volume to patients when used with non-pneumatic nebulizers. This discrepancy between set and delivered volume poses a risk to home-use patients.
Erbe USA Inc recalls 8,284 flexible cryoprobes used in surgical procedures. The devices may rupture or burst during activation, posing a risk to patient safety.
Merit Medical Systems is recalling the DuraMax Chronic Hemodialysis Catheter due to a design defect that prevents proper splitting, potentially causing hemorrhage, blood clots, device malfunction, and complications during dialysis treatment.
Merit Medical's 16F sheath introducers may fail to split properly, posing risks of hemorrhage, foreign body retention, and blood clots during vascular procedures. Approximately 368,264 units distributed worldwide are affected.
SiluetaYa Mexican Tejocote Roots Supplement Pieces (7g bottles, Lot US1220) are recalled because the product contains yellow oleander, a toxic substance. The product was distributed online to consumers in AZ, CA, NM, NY, TX, and UT.
Bakkavor is recalling roasted tomato and parmesan focaccia bread sold under multiple retail brands due to metal fragments discovered in the products. The metal originated from roasted tomatoes supplied by an ingredient supplier.
Merit Medical Systems is recalling ProGuide Chronic Dialysis Catheters due to a design defect in the sheath introducer that may not split properly. This could lead to hemorrhage, blood clots, or loss of vascular access.
Sevillo Fine Foods is recalling Slow Roasted Diced Tomatoes (24 lb bulk packages, UPC 00823338008216) because the product may contain metal fragments.
Ajinomoto Foods North America Inc. is recalling Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed (1 lb. bags) due to glass fragments 1–3 cm long and 2–4 mm wide found in the product.
Lucerne 2% Cottage Cheese 24 oz. tubs are being recalled due to the potential presence of metal spring fragments. Consumers who have purchased affected product should not consume it.