Tag: medical_devices

Dexcom Recalls Stolen G7 Glucose Sensors Following Third-Party Theft

29 May 2026 4:22 p.m. · Source: US Food and Drug Administration

Dexcom has recalled two lots of G7 continuous glucose monitoring sensors, 1725204004 and 1725069002, after they were stolen during destruction and sold by unauthorized third parties, posing risks of infection or device failure. Users should seek replacements.

Health Business Law Enforcement Medical Science Legal Education Economy Social Issues Dexcom G7 sensors Product Recall Medical Devices Diabetes Theft Pharmsource LLC Food Recalls FDA Drugs
FDA Updates Erbe Flexible Cryoprobe Recall with More Lot Numbers

28 May 2026 3:02 p.m. · Source: US Food and Drug Administration

The FDA updated its recall of Erbe Flexible Cryoprobes, adding more affected lot numbers. This Class I recall warns of serious injury or death if devices are used without correction, urging customers to contact Erbe USA with questions.

Health Business Medical Science Federal Government Product Recall FDA Erbe USA Flexible Cryoprobes Medical Devices Public Safety Health Warning Food Recalls Drugs
Philips Updates Nebulizer Guidance for Trilogy Evo Ventilators Amid Recall Clarification

28 May 2026 10:57 a.m. · Source: US Food and Drug Administration

Philips has updated guidance for nebulizer use with Trilogy Evo Ventilators, clarifying recall reasons. The FDA's Class I recall now permits non-pneumatic nebulizers under specific placement, with no new serious injuries reported since May 27.

Health Business Politics and Government Medical Science Federal Government Legal Philips Trilogy Evo Ventilators Nebulizer FDA Product Recall Medical Devices Ventilator Correction Food Recalls Drugs
FDA Issues Early Alert on ICU Medical IV Tubing Sets Over Contamination Concerns

27 May 2026 3:59 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert concerning ICU Medical IV tubing sets due to reports of black specks and particulate matter in drip chambers. ICU Medical is investigating potential contamination and patient risk, though no serious injuries have been…

Health Business Politics and Government Medical Science Federal Government Legal Social Issues ICU Medical FDA IV tubing sets Medical devices Product Alert Contamination Patient safety Food Recalls Drugs
FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks

26 May 2026 1:56 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Medline Namic Manifolds and related kits due to particulate in the fluid path. This poses a serious risk of injury or death if introduced into blood circulation, prompting immediate removal of…

Health Business Medical Science Federal Government Legal Product Recall Medline Namic Manifolds FDA Class I Recall Medical Devices Patient Safety Food Recalls Drugs
FDA Announces Serious Recall of React Health VOCSN V+Pro Ventilators

21 May 2026 2:40 p.m. · Source: US Food and Drug Administration

The FDA announced a serious recall of React Health VOCSN V+Pro Ventilators due to a manufacturing defect causing potential oxygen leaks. This could lead to reduced oxygen delivery, increased fire risk, and serious patient harm or death.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues React Health VOCSN V+Pro Ventilators Ventilator Recall FDA Oxygen Leak Medical Devices Product Recall Food Recalls Drugs
California Biolab Operator Convicted in Multi-Million Dollar COVID Test Fraud

14 May 2026 12:39 p.m. · Source: Denver FBI

A California biolab operator, Jia Bei Zhu, has been convicted of 12 counts, including wire fraud and distributing misbranded medical devices, for selling millions of fraudulent COVID-19 tests and deceiving the FDA.

Law Enforcement Business Health Legal Economy Medical Science Federal Government Jia Bei Zhu COVID-19 tests Fraud FDA Fresno Universal Meditech Inc.Medical devices FBI
Boston Scientific Issues Class I Recall and Software Correction for ACCOLADE Pacemakers

7 May 2026 3:54 p.m. · Source: US Food and Drug Administration

Boston Scientific has issued a Class I recall for ACCOLADE pacemakers and CRT-Ps, requiring a critical software update. The FDA warns that failing to correct the devices could lead to early replacement, serious injury, or death.

Health Science & Technology Business Medical Science Computers and Internet Legal Federal Government Product Recall Medical Devices Boston Scientific Pacemakers FDA Health and Wellness Software Update Food Recalls Drugs
Media Monitor: AI Adoption in Health Care Faces Technical and Regulatory Hurdles

4 May 2026 9:00 a.m. · Source: MIT Technology Review

MIT Technology Review Insights is reporting that while AI applications in health care are proliferating, developers face significant challenges in aligning technical capabilities with complex clinical and business requirements.

Politics and Government Health Business Science & Technology Federal Government Economy Medical Science Artificial Intelligence Legal Health Care FDA MIT Technology Review Medical Devices Health Technology Generative AI MIT science technology