1,264 recalls tagged with “fda regulated”.
Rising Pharma Holdings, Inc. is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg distributed nationwide in the United States. The tablets are imprinted with the wrong ID. Stop using the product and contact the manufacturer or your healthcare provider for guidance.
UIH Technologies recalled 11 units of the uCT 760 MD Computed Tomography X-ray System. Third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals and patients should stop using the device immediately and await manufacturer instructions.
Mars Foods is recalling 273 cases of Ben's Original Ready Rice Original Long Grain White, 8.8 oz, sold at multiple retailers. The recall cites the possible presence of stones in the product. Consumers should not eat this product and should email Mars Foods for a refund or replacement.
GE HealthCare recalled 102 dual-head gamma cameras used for cardiac imaging worldwide after finding that some systems past the End of Guaranteed Service could be moved without adequate detector support. This could place excessive stress on detector mounting mechanisms and may cause a detector to fall, posing life-threatening risk. Hospitals and healthcare providers should stop using the devices IM
GE HealthCare recalled 1 Optima NX dual-head gamma camera worldwide after detecting potential detector mounting failure if the unit is moved without proper support. The risk could cause a detector fall and life-threatening injury. Hospitals should stop using the device and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging for guidance.
Philips North America recalls 28 Cardiac Workstation 5000 devices, model 860439, distributed nationwide in five states. A pinched power module wire led to a short during environmental stress tests. Users should stop using the device and follow manufacturer recall instructions.
UIH Technologies recalls 3 units of Shanghai United Imaging Healthcare uMI 780 PET/CT systems after a third-party outer cover can trap between the patient table and gantry. The issue can obstruct table movement. Hospitals are urged to stop using the devices and follow recall instructions.
GE HealthCare recalled 82 Millenium Myosight dual-head gamma cameras distributed worldwide. The devices could have been moved without adequate detector mounting support. This could cause a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the cameras immediately and follow manufacturer recall instructions.
M.O.M Enterprises recalled 46,752 bottles of Organic BABY bedtime drops sold nationwide through Unknown retailers after FDA enforcement notice flagged potential yeast contamination. The product is a liquid dietary supplement for infants age 4 months and older. Parents should stop using the product immediately and contact M.O.M Enterprises for refund or replacement.
GE Medical Systems Israel recalls 11 Elscint Cardial dual-head gamma cameras used for cardiac imaging worldwide. The recall concerns detector mounting that could fail if the unit is moved without proper support. Hospitals should stop using these devices immediately and follow GE’s recall instructions.
Mars Foods recalled 315 cases of Ben's Original Ready Rice Whole Grain Brown. The product was distributed to nine states. The recall cites a possible presence of stones and urges consumers not to eat the product and to contact Mars Foods US for a refund or replacement.
UIH Technologies recalled 2 uEXPLORER MD PET/CT systems after finding third-party outer covers can trap between the patient table and gantry. The interference can occur during table movement. Hospitals and healthcare facilities should stop using the devices and await instructions from UIH Technologies LLC.
GE HealthCare recalled 292 Millenium MPR dual-head gamma cameras worldwide after discovering some units past End of Guaranteed Service may have been transported without adequate detector support. This can place excessive stress on detector mounting and could result in a detector fall with life-threatening injury. Healthcare facilities should stop using the devices immediately and follow recall PIN
Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets, 200 mg, distributed nationwide. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Healthcare providers and patients are urged to stop using the product and await guidance from Major Pharmaceuticals and Rugby Laboratories.
Noah Medical recalled 47 Galaxy System bronchoscopic visualization devices distributed to 20 US states and internationally to Hong Kong and Australia. The recall centers on password-protected Instructions for Use. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,
GE Medical Systems Israel is recalling 45 units of the Elscint SPX4 dual-head gamma camera worldwide. The recall cites a risk from transporting or relocating systems past End of Guaranteed Service without adequate detector support. Hospitals and clinics should stop using the device immediately and follow manufacturer instructions.
GE HealthCare recalled 54 Millennium MPS dual-head gamma cameras sold worldwide to healthcare facilities. A detector mounting could fail if the unit is moved after its service life ends. Hospitals should stop using the device immediately and follow manufacturer recall instructions.
Diagnostica Stago recalled 12,740 STA Liatest D-Di units distributed worldwide after a potential risk of underestimating D-Dimer levels. The two listed lots may produce falsely low results. Stop using the devices immediately and follow recall instructions from Diagnostica Stago or your healthcare provider.
UIH Technologies LLC recalled 95 uMI 550 MD PET/CT systems sold in the United States after reports that third-party outer covers can become trapped between the patient table and gantry. The covers can interfere with table movement during imaging. Hospitals and clinics should stop using the devices and follow the manufacturer's recall instructions immediately.