1,319 recalls tagged with “fda regulated”.
Distribuidora de Alimentos Sendero LLC recalled 500 Doraditas de Azucar sold in Texas. The products are missing Wheat and Soy allergen labeling on the package. Consumers should not eat them and should contact Sendero LLC for refund or replacement.
Distribuidora de Alimentos Sendero LLC recalls 2,500 Gorditas de Azucar and Doraditas distributed in Texas. The recall is due to missing Wheat and Soy allergens on the label. Consumers should stop using it and contact Sendero LLC for refund or replacement.
Cook Incorporated recalled 441 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray after identifying expiration dates that exceed true shelf life. The recall covers lots with Reference Part Numbers C-PTISY-100-HC-G-NA, C-PTISY-100-UNL-HC-G-NA and C-PTISY-100-UNS-HC-G-NA distributed worldwide. Healthcare providers must stop use and follow manufacturer recall instructions.
JFE FRANCHISING INC recalled two dumpling products sold at retailers nationwide: Dumpling Vegetable 4.5 oz (UPC 011110658067) and Loaded Dumpling Vegetable 5.7 oz (UPC 011110696953) due to a glass contamination risk. The recall is Class II with a high hazard level. Consumers should not eat the dumplings and should contact JFE FRANCHISING INC by email for refund or replacement.
Philips Medical Systems Nederland B.V. recalled 3,552 Vue Motion V12 devices worldwide, including the United States. The recall is due to a potential that mis-ordered frames during dynamic cine runs may display out of sequence. Stop using the device and follow the recall instructions provided by the manufacturer.
JFE Franchising Inc. recalls Dumpling Party Tray products and a Cheetos Flamin Hot Loaded Dumpling item after glass fragments were found in the trays. The FDA enforcement report lists glass as the foreign object hazard. Consumers should not eat these products and should seek refunds or replacements via email.
Cook Incorporated recalls 104 Wayne Pneumothorax Sets worldwide after labeling errors show expiration dates exceeding true shelf life. The recall affects reference parts C-UTPT-1020-WAYNE-IMH and C-UTPT-1400-WAYNE-112497-IMH with order numbers G56532 and G56535. Healthcare providers should stop use immediately and follow recall instructions.
Cook Medical recalled the Thal-Quick Chest Tube Tray, reference part number C-TQTSY-3200, Order G07242, due to expiration dates that exceed true shelf life. The recall is active and worldwide. The hazard is labeling that misstates shelf life. Patients and healthcare providers should stop using the affected devices immediately and follow Cook’s recall instructions.
Tornier recalls 233 surgical parts nationwide in the United States. The items were mislabelled as Tornier HRS Max products. These parts fit the Tornier HRS system only and are incompatible with the Tornier HRS Max system. Clinicians and patients should stop using the affected parts and follow recall instructions.
Cook Incorporated recalled 20 units of its Multipurpose Drainage Catheter reference ULT8.5-38-25-P-CLMS-8-RH-FS distributed worldwide. The recall cites expiration dates that exceed the product’s true shelf life. Healthcare providers and patients should stop using the affected devices immediately.
Cook Medical recalled 318 Wayne Pneumothorax Trays after labels showed expiration dates beyond true shelf life. The devices were distributed worldwide. Patients and healthcare providers should stop using these devices immediately and follow recall instructions from Cook Incorporated.
Cook Medical recalled 1,872 units of Spectrum Central Venous Catheter Trays worldwide due to expiration dates labeling that exceed true shelf life. Healthcare providers should stop using affected lots immediately and follow manufacturer instructions."
Cook Medical recalled 49 units of the Strange Bile Duct Stone Exploration Set due to labels showing expiration dates beyond shelf life. The recall is worldwide and active as of March 5, 2026. Healthcare providers were advised to stop use and follow recall instructions.
Koven Technology recalled 34 BiDop 3 Pocket Dopplers with BT2M20S8C fetal probes nationwide after regulators found the fetal indication on the labeling was not cleared under 510(k). The defect is labeling that misrepresents fetal use. Healthcare providers and patients should stop using the devices and follow recall instructions from the manufacturer.
Ajinomoto Foods North America recalled Trader Joe's Vegetable Fried Rice sold at Trader Joe's nationwide after glass fragments were found in the product. The contamination involves glass shards ranging from 1 to 3 cm long and 2 to 4 mm wide. Consumers should not eat this product and should contact Ajinomoto Foods North America for refunds or replacements.
Ajinomoto Foods North America recalls Ajinomoto Golden Tiger Vegetable Fried Rice sold at multiple retailers nationwide. Glass fragments measuring 1-3 cm long and 2-4 mm wide have been found in frozen rice. Consumers should not eat the product and should contact Ajinomoto for refunds or replacements.
Philips Medical Systems Nederland recalled 5,167 Azurion 7 M20 X-ray imaging systems sold to healthcare facilities in the U.S. and internationally. The wired foot switch can fail to initiate imaging or produce intermittent imaging. Hospitals and clinics should stop using the device and follow recall instructions from Philips, with notification by letter to affected parties.
Philips Medical Systems Nederland B.V. recalled 5,084 ALLURA Xper FD20 imaging systems sold nationwide and internationally after finding that the wired foot switch may fail to initiate X-ray imaging or perform intermittently. The defect can delay or interrupt imaging during patient care. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.
Philips Medical Systems Nederland B.V. recalls 2 ALLURA Xper FD10 OR Tables after reports that X-ray imaging may not start or may delay when using the wired foot switch. The defect could affect patients during imaging procedures. Healthcare providers should stop using the device and follow recall instructions from the manufacturer.
KC Pharmaceuticals recalled 182,424 Sterile Eye Drops AC bottles sold nationwide under multiple brands including Quality Choice Eye Drops Irritation Relief and Goodsense Ultra Lubricant Eye Drops. The recall cites a lack of assurance of sterility. Consumers should stop using the product immediately and contact KC Pharmaceuticals for guidance.