1,264 recalls tagged with “fda regulated”.
Biomet recalled 40 Juggerknot Mini Soft Anchors, model 912080, distributed nationwide in the United States. The outer carton label lists JuggerKnot 1.0mm Mini devices, but the cartons contain JuggerKnot 1.4mm Short devices. Patients and clinicians should stop using the device and follow the recall instructions provided by Biomet.
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.
NOXBOX LTD recalled 1,667 NOxBOXi Nitric Oxide Delivery System units distributed in Tennessee after reports of flow and dose fluctuations. The device can show fluctuations when the total flow through its sensor drops below 0.5 LPM. Dose fluctuations have been observed with LifePulse HFJV or conventional ventilators under certain settings. Stop using the device immediately and follow the recall. NO
BioPro recalled 147 Endo Head Ceramic implant components distributed in Texas and Michigan after packaging could compromise the sterile barrier. The defect could result in loss of sterility of the device, creating an infection risk if implanted. Clinicians and patients should stop using the devices and contact BioPro for instructions and refunds.
BioPro recalled 147 bipolar heads due to a potential packaging issue that may compromise sterility. The defect could result in infection if the device is implanted. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
Hale Inc. recalls 54 bottles of Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil sold in Kentucky after concerns of Clostridium botulinum contamination. The product was manufactured without an approved processing. Consumers who purchased the oil should not consume it and should contact Hale Inc for refund or replacement.
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 BioPro Femoral Head hip implant components sold in Texas and Michigan after a packaging defect could compromise sterility. The defect may result in loss of sterility, creating a risk of infection if implanted. Hospitals and clinicians should stop using the devices and await manufacturer instructions.
MedicalCommunications GmbH recalled 474 Ashvins HEYEX 2 / HEYEX PACS software units distributed nationwide in the United States. The affected software versions range from 2.6.0 (Build 2088) to 2.6.8 (Build 2220). The hazard is that the measured value may be smaller than the actual area, potentially affecting imaging measurements. Stop using the software immediately and follow manufacturer recall‑s
Hale recalled 54 bottles of Fresh Basil Infused Olive Oil sold in Kentucky after a recall notice citing potential botulism contamination. The FDA enforcement report H-0241-2026 documents the issue. Consumers should not consume this product and should contact Hale for refunds or replacements.
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.
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.
Chetak New York recalled over 3.5 million bags of frozen green chili on September 5, 2025. The product tested positive for Salmonella, a serious foodborne pathogen. Consumers should not consume the product and seek refunds immediately.
CHETAK NEW YORK LLC recalled over 3.5 million bags of Deep-brand PREMIUM Select Green Channa on September 5, 2025. The recall follows positive Salmonella test results. Consumers should not consume the product and seek refunds immediately.
Spacelabs Healthcare has recalled 820 DVI display cables worldwide due to shielding issues that may cause electromagnetic interference with other medical devices. The cables connect monitors used in patient care. Hospitals should stop using the affected cables and follow manufacturer recall instructions. The recall was issued by letter and is active as of 2025.
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.
Philips recalled 40 L12-5 ultrasound transducers distributed nationwide in the United States after regulators flagged labeling to define the devices' useful life. The recall concerns labeling clarity rather than a device malfunction. Healthcare providers and patients should stop using the device immediately and await instructions from Philips Ultrasound, Inc or their healthcare provider.