fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Apotex Ketorolac Tromethamine Ophthalmic Solution Recall 2025: 493,468 Bottles Nationwide
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Chetak New York Recalls Hot Green Chillies Over Salmonella Risk
Chetak New York Recalls Frozen Tuvar Lilva Due to Salmonella
Chetak New York recalled over 3.5 million bags of frozen Tuvar Lilva on September 5, 2025. The product tested positive for Salmonella, posing a significant health risk. Consumers should not consume this product and seek a refund or replacement immediately.
GE Medical Systems AW Server 2.0, AW Server 3.0, 3.1, 3.2 Recalled For Security Breach Risk (2025)
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Spacelabs Healthcare DVI Display Cables Recalled for EMI Risk in 2025 (012-0895-12, 820 Units)
Philips Ultrasound X3-1 Transducer Recalled for Labeling Clarification in 2026 (17 Units)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound Recalled 11 Mini Multi TEE Transducers Over Useful-Life Labeling (2025)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips X7-2 Ultrasound Transducer Recall for 5 Units Nationwide (2026)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips 3D6-2 Ultrasound Transducer Recalled for Labeling Clarification (17 Units, 2025)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound C9-4 Transducer Recalled for Lifespan Labelling — 1 Unit (2025)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound L17-5 Transducer Recalled for Useful-Life Labeling (2025)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Spacelabs Healthcare Recalling 8,179 DVI Display Cables Over EMI Interference Risk (2025)
Philips Ultrasound S5-2 Transducer Recall 2025 - 1 Unit Nationwide
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Chetak New York Recalls Frozen Vegetables Due to Salmonella Risk
Endo USA Recalls 1,041 Cartons of Everolimus 5mg Tablets Over IP-C Impurity (2025)
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
GE Healthcare CSCS V3 MAS800 Central Station Recalled for 2,306 Units Worldwide (2025)
CHETAK NEW YORK Recalls Premium Select Snake Gourd Over Salmonella Risk
CHETAK NEW YORK recalled 3,509,532 bags of its PREMIUM Select Snake Gourd on September 5, 2025. The product tested positive for Salmonella, posing a serious health risk. Consumers should not eat the product and seek refunds.
Philips Recal Size 40 L12-5 Ultrasound Transducers for Labeling Life Span Recall (2026)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.