1,264 recalls tagged with “fda regulated”.
Kroger 70% isopropyl alcohol recall active nationwide, 1860 bottles involved. The recall covers Kroger-branded rubbing alcohol distributed by The Kroger Co. No injuries are reported in the notice. Consumers and healthcare providers should stop using the product immediately and seek guidance from a healthcare professional.
TopCare Health recalled 60 bottles of 70% isopropyl alcohol distributed nationwide by The Kroger Co. The recall cites cross contamination with other products as the hazard. Consumers and healthcare providers should stop using the product immediately and contact the seller for guidance.
AvKare recalls 2,003 cartons of CHLORPROMAZINE HYDROCHLORIDE 100 mg tablets sold nationwide in the United States after a foreign substance was found. The FDA-listed Class II recall is in effect as of 2025-08-25. Stop using the product and contact AvKare or your healthcare provider for guidance.
LeMaitre Vascular recalls 10 Artegraft Collagen Vascular Grafts distributed internationally to Great Britain and Switzerland, with no US distribution. The devices were labeled incorrectly and lacked CE and UKCA marks and missing patient documents. Healthcare providers and patients should stop using the devices and follow recall instructions immediately.
FDA-listed recall covers 49,275 tubes sold nationwide. Ultra Violette Velvet Screen Blurring Mineral Skinscreen distributed by Grace & Fire USA Inc. Tested SPF results ranged from 4 to 64. Consumers should stop using the product immediately and contact Grace & Fire USA for guidance.
CooperVision recalled 180 Softmed Breathables toric daily disposable contact lenses after one lot was manufactured with an invalid sterilization cycle. The lenses were distributed across Florida, Kentucky, North Carolina and Wisconsin. Patients should stop using the affected lenses immediately and follow the recall instructions.
Ultra Violette Mini Mates SPF 50 kit sold nationwide in the U.S. is recalled. Testing showed SPF results ranging from 4 to 64. The recall is issued by Grace & Fire USA Inc. The public was notified by letter.
CooperVision recalled 4,140 MyDay Toric contact lenses sold nationwide in the United States. The recall cites an invalid sterilization cycle for one lot. Patients should stop wearing the lenses and consult their eye care providers for guidance.
CooperVision recalled one lot of Voyant 1-Day Premium Toric contact lenses sold nationwide in the United States after an invalid sterilization cycle was detected. The recall affects 90 units distributed in Florida, Kentucky, North Carolina and Wisconsin. Patients should stop using the lenses immediately and contact their eye care professional for guidance.
GE Medical Systems recalled 29,225 MAC VU360 Acquisition Trunk Cable and Module Holder devices worldwide. The defect can occur when a user inserts the Acquisition Module incorrectly, causing excessive bending and wear of the Acquisition Trunk Cable. A damaged sheath or exposed wires may appear. If a damaged cable is not identified and removed from service, it can overheat. Stop use immediately and
Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges sold nationwide in the United States. The recall stems from a lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using these cartridges and follow Abbott's recall instructions.
Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.
Latitude 36 Foods recalled 46,800 master-pack units of Honey Balsamic dressing distributed to a single customer in California. The dressing comes in 3.4-ounce plastic pouches. Lot numbers 131105-3335 and 131105-3335A are affected. Consumers should not consume the product and should contact Latitude 36 Foods for refund or replacement via email.
Frontier Devices recalled 3,790 units of the 12 mm Distraction Pin, REF 301.912S1, distributed nationwide in the United States. The recall cites labeling that includes shelf life which has not been validated. The high-risk device category reflects potential documentation and shelf-life concerns. Healthcare providers and patients should follow recall instructions and contact the manufacturer for a回
Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges sold nationwide in the United States. The recall cites a lack of 510(k) premarket clearance to reflect updated sample type for lactate and measurement ranges for pH and PO2. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Taylor Farms Retail issued a Class I recall for 8,284 salad kits after undeclared sesame and soy allergens were found inside a dressing packet. The recall covers products labeled under Taylor FARMS Honey Balsamic Salad Kit sold across 19 states. Consumers should not eat the product and should seek refunds or replacements from Taylor Farms Retail.
Frontier Devices recalled the 301.914S2 14 mm Distraction Pin distributed nationwide in the US. The recall was issued for labeling that includes shelf life not validated. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Frontier Devices recalls 160 units of 301.912S2 12 mm distraction pins distributed nationwide. The recall lists shelf-life labeling that has not been validated. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.
Frontier Devices recalled 2,700 units of REF 301.914S1 14 mm Distraction Pin sold nationwide by multiple retailers. The labeling includes shelf life that has not been validated. Healthcare providers and patients should stop using this device immediately and follow the manufacturer’s recall instructions.