185 recalls tagged with “federal law violation”.
GE HealthCare recalled 292 nuclear medicine gamma cameras on September 12, 2025. The devices may have been relocated without proper support, risking detector falls. This poses a serious risk of life-threatening injuries.
GE HealthCare recalled 64 units of the Elscint Model 4XX gamma camera on September 12, 2025. The recall affects systems that lack adequate support during transport, risking detector falls. If the detectors fall, they can cause serious injuries to patients and healthcare providers.
GE HealthCare recalled a dual-head nuclear medicine gamma camera on September 12, 2025, after identifying a risk of detector falls. One unit is affected, posing a high risk of life-threatening injury. Users must stop using the device immediately and follow manufacturer instructions.
GE HealthCare recalled 205 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall affects models that may have been relocated without proper detector support, leading to potential falls. This issue poses a high risk of life-threatening injury.
Olympus Corporation of the Americas recalled the BF-H1100 bronchovideoscope on September 11, 2025, due to safety concerns when used with certain medical equipment. The recall affects 1,867 units distributed outside the U.S. Patients and healthcare providers should stop using the device immediately.
Olympus Corporation of the Americas recalled the Bronchovideoscope BF-1TQ170 on September 11, 2025. The recall affects 2,092 units distributed outside the U.S. Additional instructions for safe use with laser and other therapies prompted this action.
Olympus Corporation of the Americas recalled 3 bronchovideoscopes on September 11, 2025, due to safety clarification updates. The recall affects 1,987 units distributed outside the US. Healthcare providers must stop using the device immediately to ensure patient safety.
Insulet recalled 174,013 units of the Omnipod 5 iOS application on September 11, 2025. A software error can lead to the duplication of numbers during manual entry. This increases the risk of insulin overdelivery, potentially causing hypoglycemia.
Olympus Corporation recalled 4,297 EVIS EXERA III bronchoscopes on September 11, 2025. The recall follows updates to the instructions for use regarding safe operation with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device immediately.
Par Pharmaceutical recalled 1,041 cartons of Everolimus tablets on September 5, 2025. The recall stems from failed impurities and degradation specifications. Consumers should stop using the product immediately.
Zydus Pharmaceuticals recalled 4,440 bottles of Entecavir Tablets on September 4, 2025. The recall follows failure to meet impurity and degradation specifications. Consumers should stop using the affected tablets immediately and contact their healthcare provider.
Philips Medical Systems Nederland B.V. recalled 46 imaging systems on September 3, 2025. Deterioration of internal components may lead to loss of motorized movements. Healthcare providers must stop using the systems immediately and follow recall instructions.
Philips Medical Systems Nederland B.V. recalled 115 Allura Xper FD20/20 medical imaging devices on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system during startup. The recall affects 34 devices in the U.S. and 81 internationally.
Philips Medical Systems Nederland B.V. recalled the Allura Xper FD10C model on September 3, 2025, due to a potential BIOS battery issue. The battery may deplete faster than expected, halting system startup without warning. Only two units are affected in the U.S.
Philips Medical Systems recalled 313 cardiac monitors on September 3, 2025, due to a BIOS battery issue. The battery may deplete unexpectedly, halting the device's start-up process without warning. Patients and healthcare providers must stop using the device immediately.
Philips Medical Systems Nederland B.V. recalled eight Allura Xper FD20/15 OR Tables on September 3, 2025. The BIOS battery may deplete unexpectedly, halting the system's start-up process. This recall affects two units in the U.S. and six units internationally.
Cardinal Health recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination risks. A specific lot contained a foreign substance with a detected micro-organism, although no contamination was found on the tablets. Consumers must stop using the product immediately and seek guidance from healthcare providers.
Baxter Healthcare recalled 958,351 IV solution sets on August 29, 2025. The products may leak, posing a high risk to patients. Healthcare providers and patients must stop using these devices immediately.
Granules Pharmaceuticals Inc. recalled 11,909 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The recall stems from failure to meet impurities and degradation specifications. Healthcare providers and consumers must stop using the product immediately.
Lulive recalled 12,000 dressers on August 28, 2025, due to a serious tip-over hazard. The recalled models are unstable if not anchored to the wall, posing risks of injury or death to children. Consumers should stop using the dressers immediately and seek a full refund.