Tag: medical_devices

FDA Announces Class I Recall for BMC Luna G3 APAP Due to Firmware Flaw

8 Sep 2026 4:53 p.m. · Source: US Food and Drug Administration

BMC Medical's Luna G3 APAP devices face a Class I recall due to a firmware defect. The flaw can cause therapy failure, potentially leading to serious health consequences, with up to 196 units possibly still affected.

Health Business Science & Technology Medical Science Computers and Internet Legal Product Recall Medical Devices FDA BMC Medical Co., Ltd.Luna G3 APAP Firmware Defect Class I Recall Food Recalls Drugs
FDA Issues Class I Recall for Boston Scientific Spinal Cord Stimulator Leads

3 Sep 2026 4:18 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's unused Infinion CX Leads, part of Spinal Cord Stimulator Systems. Mechanical stress can cause lead fractures, leading to inadequate stimulation and 1,081 reported serious injuries. This recall affects only…

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FDA Issues Early Alert for Avid Medical IV Start Kit Recall Over Fungal Contamination

28 Aug 2026 2:10 p.m. · Source: US Food and Drug Administration

Avid Medical is recalling IV Start Kits due to fungal contamination risk from included BD ChloraPrep applicators. The FDA issued an Early Alert, warning of serious health consequences like infection and sepsis, though no injuries or deaths have been reported.

Health Business Medical Science Legal Education Social Issues Avid Medical IV Start Kit Product Recall FDA Aspergillus penicillioides BD ChloraPrep Medical Devices Food Recalls Drugs
AVID Medical Issues Class I Recall for Kits with Contaminated Medline Manifolds

27 Aug 2026 12:22 p.m. · Source: US Food and Drug Administration

AVID Medical has issued a Class I recall for convenience kits containing Medline Namic Star Off Handle Manifolds due to particulate contamination. The FDA warns of serious injury or death if these components are not removed, though no incidents have…

Health Business Medical Science Federal Government Legal AVID Medical Medline Namic Star Off Handle Manifolds Class I Recall FDA Product Recall Medical Devices Food Recalls Drugs
FDA Issues Early Alert for Medline Kits with Recalled Fungal-Contaminated Applicators

24 Aug 2026 10:36 a.m. · Source: US Food and Drug Administration

FDA issues an "Early Alert" for Medline convenience kits containing recalled BD ChloraPrep applicators due to potential fungal contamination. These kits are recommended for removal to prevent serious health risks, including infection and sepsis.

Health Business Science & Technology Medical Science Federal Government FDA Medline BD ChloraPrep Product Recall Fungal Contamination Medical Devices Aspergillus penicillioides Food Recalls Drugs
FDA Alerts Public to Recalled Components in Medical Action Industries Epidural Kits

21 Aug 2026 2:43 p.m. · Source: US Food and Drug Administration

Medical Action Industries epidural kits may contain recalled Huons Co., Ltd. sodium chloride ampules, posing risks like infection, organ failure, and paralysis. The FDA is aware, and customers are advised to correct kits before use.

Health Business Medical Science Federal Government Social Issues Epidural Kits Medical Action Industries Sodium Chloride Product Recall Huons Co., Ltd.FDA Medical Devices Food Recalls Drugs
Medline Issues Class I Recall for Kits with Compromised Anesthetic

20 Aug 2026 6:02 p.m. · Source: US Food and Drug Administration

Medline has initiated a Class I recall for convenience kits containing B. Braun components with Huons Bupivacaine Hydrochloride. This correction addresses serious risks like infection and reduced anesthetic effectiveness, urging customers to remove affected parts.

Health Business Law Enforcement Medical Science Legal Social Issues Education Medline B. Braun Huons Bupivacaine Hydrochloride Class I Recall Medical Devices Product Recall FDA Food Recalls Drugs
Medline Issues Class I Recall for Kits Containing Contaminated Pain Management Components

12 Aug 2026 2:42 p.m. · Source: US Food and Drug Administration

Medline has issued a Class I recall for convenience kits containing ICU Medical pain management components due to a Huons Bupivacaine Hydrochloride recall. This correction addresses serious risks including infection and neurological complications.

Health Business Medical Science Legal Social Issues Medline ICU Medical Huons Bupivacaine Hydrochloride Product Recall Medical Devices Pain Management Food Recalls FDA Drugs
Medline Advises Correction for Kits Containing Recalled BD Chloraprep Applicators

12 Aug 2026 2:42 p.m. · Source: US Food and Drug Administration

Medline advises customers to correct convenience kits by removing recalled BD Chloraprep applicators due to a potential sterility breach. The FDA is aware of the issue, which could lead to infection, though no serious injuries or deaths have been reported…

Health Business Medical Science Legal Education Medline BD Chloraprep Product Recall FDA Sterility Breach Medical Devices Infection Food Recalls Drugs
Hamilton Medical Recalls Breathing Circuit Sets Over Expiratory Valve Malfunction

11 Aug 2026 2:30 p.m. · Source: US Food and Drug Administration

Hamilton Medical has recalled specific coaxial breathing circuit sets for HAMILTON-C1, T-1, and MR1 ventilators. The FDA is aware of the issue, where an expiratory valve malfunction can impede gas flow, potentially causing serious patient injury and inadequate ventilation.

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Governor Whitmer Announces 182 New Jobs, $42.2 Million Investment in Michigan Business Expansions

11 Aug 2026 10:03 a.m. · Source: Office of Michigan Governor

Governor Whitmer announced 182 new jobs and over $42.2 million in capital investment from three business expansions across Mid and West Michigan. Vertical Autonomy, R.W. LaPine, and Shoulder Innovations are growing, boosting advanced manufacturing, skilled trades, and medical technology sectors.

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Medline Recalls Neonatal/Infant Breathing Circuits Over Electrical Connector Failures

10 Aug 2026 2:36 p.m. · Source: US Food and Drug Administration

Medline Industries, LP has recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits nationwide due to electrical connector failures. The issue, affecting 0.011% of devices, can lead to unconditioned gas delivery, posing risks to infant health. Consumers should discard affected products.

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Liebel-Flarsheim Recalls OPTIRAY Imaging Vials Over Particulate Contamination

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

Liebel-Flarsheim Company, LLC is recalling OPTIRAY Imaging Bulk Package vials nationwide and in Mexico due to particulate matter. The recall affects hospitals and clinics, posing risks like blood clots, though no adverse events have been reported yet.

Health Business Medical Science Legal Education Liebel-Flarsheim Company, LLC OPTIRAY Imaging Bulk Package Product Recall Particulate Matter Ioversol Injection Medical Devices Healthcare Food Recalls FDA Drugs
BD Recalls Intraosseous Needle Sets Over Removal Difficulties, Linked to Deaths

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

BD has issued a nationwide recall for specific lots of its Intraosseous Vascular Access System Needle Sets due to difficulties removing the obturator. This critical issue has been associated with serious injuries and four patient deaths, prompting urgent action.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues Product Recall BD (Becton, Dickinson and Company)Intraosseous Vascular Access System Needle Sets Medical Devices Patient Safety FDA Food Recalls Drugs
FDA Alerts Public to Serious Issues with BD Intraosseous Needle Sets

4 Aug 2026 1:55 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding specific lots of BD Intraosseous Vascular Access System Needle Sets due to manufacturing defects causing removal difficulties, leading to 45 serious injuries and four deaths.

Health Business Science & Technology Medical Science Legal Social Issues Becton Dickinson Intraosseous Vascular Access System Needle Sets FDA Medical Devices Product Recall Patient Safety Food Recalls Drugs
Argon Medical Issues Class I Recall for Kits with Huons Lidocaine

30 Jul 2026 12:41 p.m. · Source: US Food and Drug Administration

Argon Medical issued a Class I recall for convenience kits containing Huons lidocaine, citing risks like infection and meningitis. The FDA warns of serious injury or death if uncorrected, with two serious injuries reported.

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FDA Issues Early Alert on Baxter Duo-Vent Solution Sets Over Air Bubble Risk

20 Jul 2026 12:42 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Baxter Duo-Vent solution sets, which may introduce air bubbles into IV lines, posing serious risks like stroke or death for vulnerable patients. Baxter recommends removal of affected lots.

Health Business Politics and Government Medical Science Federal Government Social Issues Baxter Duo-Vent solution sets Air bubbles Medical devices FDA Product Recall Patient safety Food Recalls Drugs
FDA Announces Class I Recall for Arrow International Convenience Kits

16 Jul 2026 1:03 p.m. · Source: US Food and Drug Administration

Arrow International has issued a Class I recall for convenience kits containing Huons-manufactured lidocaine, bupivacaine, and saline ampules. The FDA warns of serious injury or death if uncorrected, citing risks like infection and ineffective pain control from the compromised injectables.

Health Business Medical Science Legal Economy Product Recall Medical Devices Arrow International Huons Co. Ltd FDA Lidocaine Bupivacaine Food Recalls Drugs
B. Braun Recalls Spinal Anesthesia Kits Due to Huons Bupivacaine Recall

16 Jul 2026 10:58 a.m. · Source: US Food and Drug Administration

B. Braun Medical, Inc. has recalled spinal anesthesia kits containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, due to serious risks including infection and meningitis. The FDA has classified this as the most serious type of recall.

Health Business Medical Science Legal Product Recall B. Braun Medical Huons Co. Ltd.Bupivacaine Hydrochloride Spinal Anesthesia Kits FDA Medical Devices Food Recalls Drugs
Memphis Gynecologist Sentenced to 20 Years for Medical Device Adulteration and Healthcare Fraud

14 Jul 2026 10:33 a.m. · Source: FBI

Sanjeev Kumar, a Memphis gynecologist, received a 20-year prison sentence for adulterating medical devices and healthcare fraud. He performed over 15,000 procedures with unsafe devices on Medicare and Medicaid patients, netting millions.

Health Law Enforcement Politics and Government Medical Science Legal Federal Government Social Issues Sanjeev Kumar Memphis Gynecologist Healthcare Fraud Medical Devices Adulteration Patient Safety FBI
OFAC Issues New General License for Democratic Republic of Congo

10 Jul 2026 10:34 a.m. · Source: US Treasury

OFAC has issued a new general license for the Democratic Republic of the Congo, authorizing transactions for agricultural commodities, medicine, medical devices, and other essential goods and services, easing certain sanctions.

Politics and Government Business Health Federal Government Economy Trade Medical Science Africa Legal OFAC Democratic Republic of the Congo General License 2 Sanctions Agricultural Commodities Medicine Medical Devices US Treasury
FDA Issues Early Alert for Medical Action Industries Convenience Kit Recall

9 Jul 2026 2:16 p.m. · Source: US Food and Drug Administration

FDA issues early alert for Medical Action Industries' Convenience Kits due to particulate in Medline Manifolds. The recall warns of serious injury or death risk from particulates entering blood circulation, urging immediate removal of affected lots.

Health Business Science & Technology Medical Science Federal Government Legal Product Recall Medical Devices FDA Medical Action Industries Medline Angiography Kits Particulate Contamination Food Recalls Drugs
Medline Recalls Convenience Kits Over Sterility Concerns in Applicators

9 Jul 2026 1:26 p.m. · Source: US Food and Drug Administration

Medline advises customers to remove convenience kits containing BD ChloraPrep and FREPP Clear applicators due to a sterility breach risk. The FDA alert highlights potential microbial contamination and infection, though no serious injuries or deaths have been reported as of…

Health Business Medical Science Legal Federal Government Medline FDA Product Recall Sterility Breach BD ChloraPrep FREPP Clear Medical Devices Food Recalls Drugs
FDA Alerts Public to Serious Infusion Pump Issues with Fresenius Kabi Ivenix Devices

8 Jul 2026 7:10 a.m. · Source: US Food and Drug Administration

The FDA has issued a serious alert for Fresenius Kabi's Ivenix Large Volume Infusion Pumps due to software and touchscreen issues. These corrections address risks of treatment delays or interruptions, with the FDA classifying them as the most serious type…

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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.

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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.

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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