Device approvals, testing, diagnostics, safety alerts, and technology updates.
FDA posted a Class 2 device recall for certain VITROS 5600 chemistry analyzer software. FDA says some software versions (3.8.0+) may not correctly notify users when Signal Reagent Packs are past expiration, which could increase the risk of no results or erroneous results. Here’s what patients, caregivers, and clinicians can do next if results seem unexpected.
The FDA says interruptions in stereotactic breast biopsy needle supply are expected to continue through the end of Q1 2027. If your biopsy is delayed, use this checklist—based on FDA and ACR guidance—to ask about timing, prioritization, and backup options.
FDA posted a voluntary correction for certain Omnipod Pod lots (May 26, 2026) that may under-deliver insulin. Check your Pod lot, watch for high glucose/ketones, and know when DKA warning signs mean call 911 or go to the ER.
On July 14, 2026, the FDA updated a Class I correction for Baxter Volara System single-patient-use circuits. The concern: possible air and medication leakage from the nebulizer cup when the cup isn’t properly locked after medication is added. Here’s how to check if your circuits are affected, what to do before each home therapy session, and when to get urgent help.
FDA posted a May 26, 2026 voluntary medical device correction for certain Omnipod 5, Omnipod DASH, and Omnipod Eros (insulin management system) pod lots due to a manufacturing issue that could cause insulin under-delivery. Here’s how to check your pod lot and when DKA warning signs mean you need emergency care.
The FDA says a U.S. shortage of stereotactic breast biopsy needles may affect care through March 2027. If your biopsy is delayed, ask how urgent your finding is, whether another biopsy approach or location is appropriate, and when your next follow-up is scheduled.
If your Omnipod 5, Omnipod DASH, or Omnipod Eros pod is on the May 26, 2026 FDA correction list, FDA says to stop using it and change it right away. Check the lot number, watch for signs of high blood sugar or diabetic ketoacidosis, and seek urgent care if symptoms suggest insulin is not getting through.
FDA says people using recalled TRUE METRIX meters should switch to another way to test blood sugar if possible, but should keep testing until an alternative is available.
The FDA says people using affected TRUE METRIX blood glucose meters should switch to another testing method if possible, but should not stop testing until a backup is in place. The problem is that one E-5 error code can mean either a test-strip problem or a glucose reading above 600 mg/dL.
FDA posted two separate 2026 Omnipod safety actions. Here is how to check affected Pods, spot possible insulin under-delivery, and know when high blood sugar may be an emergency.
The FDA has warned about two separate diabetes device problems: certain Omnipod pods that may under-deliver insulin and TRUE METRIX blood glucose meters that can show an E-5 error code for more than one reason. For people who depend on these devices, the key steps are to check whether a device is affected, keep monitoring blood sugar, and follow replacement or labeling instructions from the manufacturer and FDA.
The FDA has posted a Class II recall for specific lots of the QuickVue Dipstick Strep A Test. The action matters because rapid strep tests help guide next steps for sore throats, and a negative result is not always the final word — especially in children and teens with symptoms.
The FDA says certain TRUE METRIX blood glucose monitoring systems need updated instructions for an E-5 error code. For people who rely on quick glucose readings to make diabetes decisions, the alert matters because a meter problem can delay recognition of very low or very high blood sugar.
The FDA says some TRUE METRIX blood glucose meters can show the same E-5 code for two different problems: a very high blood sugar reading or a test strip error. That confusion can delay treatment or lead to the wrong response. The agency says people should move to an alternative testing method if possible, but keep testing until a backup is ready.
The FDA says a Class I recall covers TRUE METRIX blood glucose monitoring systems because an E-5 error code can mean either very high blood sugar or a strip problem. That mix-up can delay treatment or lead to the wrong response, so users should know the warning signs, confirm what device they have, and check the latest FDA guidance.
The FDA is using Early Alerts to warn the public faster about some potentially serious medical device problems. If a device, kit, or lot you use is named in a notice, the safest next step is to read the FDA and manufacturer instructions closely and follow the device-specific guidance.
A new JAMA Internal Medicine estimate puts CT scan safety back in focus. Here’s what the model found, what it did not prove, and what to ask before imaging.
The FDA says phone settings or software problems can disrupt diabetes device alerts, raising the risk of missed low blood sugar warnings and delayed treatment.
FDA-authorized medical AI is already common in scans and workflow tools. Here’s what authorization means, what it does not, and what patients should ask.
Some medical AI tools are FDA-regulated, but authorization is not a promise of equal accuracy in every clinic. Here’s what patients should ask.
A March 4, 2026 FDA update says families should use standard choking first aid first, not reach for a suction device. Here’s how to recognize severe choking and what to do for adults, children, and infants.
The FDA has classified a recall for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors as Class I, its most serious recall type. The issue is falsely low glucose readings from some sensor lots. Here is what is affected, what is not, how to check your sensor, and what to do if a reading does not match how you feel.
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