Tag: medical_devices

FDA Expands Medline Catheter Recall Over Particulate Risk

18 Jun 2026 4:34 p.m. · Source: US Food and Drug Administration

The FDA has expanded a recall of Medline Industries' reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. This Class I recall warns of serious injury or death, though no incidents have been reported.

Health Politics and Government Medical Science Federal Government Legal FDA Medline Industries Catheter Recall Electrophysiology Ultrasound Medical Devices Product Recall Food Recalls Drugs
Windstone Medical Packaging Recalls Kits Over Contaminated Alcohol Prep Pads

16 Jun 2026 4:55 p.m. · Source: US Food and Drug Administration

Windstone Medical Packaging recalls custom convenience kits due to contaminated Cardinal Health alcohol prep pads. The FDA issued an Early Alert, warning of infection risks from Paenibacillus phoenicis, especially for vulnerable patients.

Health Business Politics and Government Medical Science Federal Government Social Issues Product Recall Medical Devices Windstone Medical Packaging Cardinal Health Alcohol Prep Pads Infection Risk FDA Food Recalls Drugs
FDA Issues Warning to SNOO Smart Sleeper Manufacturer Over Unauthorized Products and Unsanitary Conditions

15 Jun 2026 6:51 p.m. · Source: US Food and Drug Administration

The FDA has warned Happiest Baby, Inc., maker of SNOO Smart Sleeper, for selling unauthorized sleep sacks and hospital bundles, and for unsanitary refurbished units and mold reports, urging caution for users.

Health Politics and Government Business Medical Science Federal Government Legal Social Issues Education FDA SNOO Smart Sleeper Happiest Baby, Inc.Warning Letter Medical Devices Product Safety Infant Care Food Recalls Drugs
FDA Warns Against Use of Recalled Bupivacaine Injections from Huons Co., Ltd.

12 Jun 2026 1:31 p.m. · Source: US Food and Drug Administration

Huons Co., Ltd. has recalled Bupivacaine Hydrochloride in Dextrose Injection, USP, due to quality issues. Medline advises customers to remove these injections from convenience kits, as their use poses risks of infection, inflammation, and severe neurological complications.

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FDA Issues Early Alert for Baxter Volara System Circuits Due to Leakage Risk

11 Jun 2026 1:15 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding Baxter's Volara System single-patient use circuits, which may leak air and medication. This issue can lead to ineffective therapy and patient desaturation.

Health Business Science & Technology Medical Science Legal Social Issues Baxter Volara System FDA Medical Device Correction Air Leakage Patient Safety Medical Devices Food Recalls Drugs
BD Recalls ChloraPrep and FREPP Applicators Due to Fungal Contamination Risk

9 Jun 2026 4:25 p.m. · Source: US Food and Drug Administration

BD has voluntarily recalled specific lots of ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators due to potential fungal contamination with Aspergillus penicillioides, which could lead to serious infections.

Health Business Medical Science Legal Education Product Recall BD ChloraPrep FREPP Fungal Contamination Aspergillus penicillioides Medical Devices Food Recalls FDA Drugs
BD Recalls ChloraPrep and FREPP Applicators Over Fungal Contamination Risk

8 Jun 2026 2:22 p.m. · Source: US Food and Drug Administration

BD has recalled specific lots of ChloraPrep and FREPP applicators due to Aspergillus penicillioides contamination. This poses risks of serious infection, sepsis, and death, prompting immediate discontinuation and destruction of affected units.

Health Medical Science Federal Government Legal Social Issues BD ChloraPrep FREPP Product Recall Aspergillus penicillioides FDA Medical Devices Food Recalls Drugs
FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets

8 Jun 2026 12:47 p.m. · Source: US Food and Drug Administration

FDA issues an Early Alert regarding Hamilton Medical coaxial breathing circuit sets. Certain lots may not perform as intended, leading to impaired exhalation and four reported serious injuries.

Health Business Science & Technology USA Medical Science Federal Government FDA Hamilton Medical Breathing Circuit Sets Medical Devices Early Alert Respiratory Compromise Patient Safety Food Recalls Drugs
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Over Oxygen Delivery Risk

5 Jun 2026 2:50 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for GE HealthCare Infant Resuscitation Systems due to loose blender knob shafts. This defect could cause incorrect oxygen delivery, posing risks of hypoxia or hyperoxia to infants, though no serious injuries are reported.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues GE HealthCare Infant Resuscitation Systems FDA Medical Devices Oxygen Concentration Product Recall Patient Safety Food Recalls Drugs
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…

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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: 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.

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