794 recalls tagged with “infant product”.
Gina Marie Bakery LLC recalled 172 cases of Italian Sesame Cookies after discovering undeclared sesame and artificial colorings. The recall began with CT state actions and was notified to FDA on 09/10/2025 with customer notification on 09/11/2025. Consumers should not eat these cookies and should seek refunds or replacements.
Gina Marie Bakery LLC recalled 172 cases of Toasted Cherry Biscotti after undeclared Red 40 was found. The recall originated with a Connecticut notice and was reported to the FDA on 2025-09-10. Consumers who purchased this product should not consume it and should contact Gina Marie Bakery LLC for refund or replacement.
Gina Marie Bakery LLC recalls 172 cases of Vanilla Chocolate Dipped Cookies after undisclosed Red 40 pigment was found. The recall was initiated by the state of Connecticut and notified to FDA on 2025-09-10. Consumers who bought the cookies should not eat them and should seek refunds or replacements.
Abbott recalls 399 TactiFlex Sensor Enabled Ablation Catheters after reports of tip detachment during packaging removal. The recall covers devices worldwide. Stop using the device immediately and follow manufacturer instructions.
Whole Foods Market recalled 6-pack granola sold at one Philadelphia store after undeclared wheat, sesame and cashew were found. The product was labeled incorrectly. Consumers should not eat the product and should seek refund or replacement from WFM Purchasing, LP.
BioPro recalled 147 femoral head components distributed in the US. The devices cover metal cobalt chromium and ceramic heads in sizes 22, 28, 32, 36 and 40 millimeters. The recall cites a packaging defect that could compromise the sterile barrier. If implanted, the loss of sterility could pose infection risk. Hospitals and surgeons should follow BioPro recall instructions immediately.
Draeger recalls 223 Atlan A350XL anesthesia workstations distributed in 25 states and many countries after reports of piston ventilator failure and mechanical ventilation failures. The recall affects units imported from Draegerwerk AG and Co. KGaA. Stop using the device immediately. Contact Draeger for instructions and patient safety guidance.
Beckman Coulter recalled three boxes of MicroScan Neg Multidrug Resistant MIC 1 panels distributed internationally, including Poland. A manufacturing issue caused incorrect processing in in vitro multidrug resistance testing. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions for recall communications.
Lee K of NY Inc. recalls 43 units of PINOCCHIO CATERING Aged Kimchi Mackerel sold in New York and New Jersey for undeclared milk and shrimp. The recall is Class I with a high hazard. Consumers should not consume the product and should contact the company for refunds or replacements.
Iantrek recalled 1,262 CycloPen CP-300 Cyclodialysis System units distributed nationwide to medical facilities. The recall stems from a potential compromise to sterile packaging integrity. Hospitals and clinics should stop using the device immediately and follow Iantrek’s recall instructions via email.
Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments, CRX-120 models, distributed nationwide to healthcare facilities. The recall cites potential compromised integrity of the sterile packaging. Healthcare providers and patients should stop using the device immediately and follow recall instructions via the manufacturer.
Sandoz Inc. recalled 263 vials of Cyclophosphamide injection distributed nationwide in the United States. The recall cites cGMP deviations due to a temperature excursion during transportation. Healthcare providers and patients should stop using the product and contact Sandoz for guidance.
Two Philips Ultrasound L17-5 transducers distributed nationwide to hospitals are recalled. The recall targets labeling that defines the devices' useful life. Stop using the transducers and follow Philips Ultrasound's instructions. Hospitals should contact Philips Ultrasound for guidance.
Philips Ultrasound recalled 1 unit of the C9-4 Ultrasound Transducer, Model No. 989605365021, distributed nationwide in the United States. The recall focuses on clarifying and labeling the device’s useful life. Healthcare providers and patients should stop using the device immediately and follow Philips’ instructions for replacement or further steps.
GE Healthcare recalled 2,306 CSCS V3 MAS800 Central Station desktops worldwide after identifying a software fault that can trigger a continuous reboot cycle. The issue can result in a loss of central monitoring for connected patients. Hospitals should stop using the affected devices and follow the recall instructions from GE HealthCare and Wipro GE Healthcare Private Ltd.
Apotex Inc. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution sold nationwide in the US. The recall cites lack of assurance of sterility due to improper bottle sealing. 151,034 bottles affected. Consumers should stop using the product immediately.
GE Medical Systems recalled 7,302 AW Server models worldwide, including 1,381 units in the U.S., after identifying a security vulnerability that could expose patient data. The defect could allow a malicious actor to compromise confidentiality, integrity and availability of information. Healthcare providers should stop using the devices immediately and follow manufacturer instructions for recall.
Philips Ultrasound recalled 2 units of the Philips OMNI II TEE Ultrasound Transducer sold nationwide through multiple retailers. The recall seeks labeling clarification to define the transducer's useful life. Healthcare facilities should stop using the devices and follow Philips recall instructions.
Spacelabs Healthcare recalls 8,179 DVI display cables worldwide after EMI interference could affect medical monitors. The cables connect 6-foot DVI-I to DVI-I devices used with the 91390 and 91393 monitors. Healthcare providers should stop using affected cables and follow recall instructions.
Makita U.S.A. recalls 3 cordless grease guns and 4 grease gun hoses due to a laceration hazard. Serial-numbered units are affected. Stop using the recalled equipment immediately and contact Makita for a free replacement hose.