Tag: medical_device_recall

FDA Issues Early Alert for AVID Medical Kits Containing Recalled Sodium Chloride

2 Sep 2026 1:25 p.m. · Source: US Food and Drug Administration

AVID Medical convenience kits contain recalled sodium chloride ampules, raising sterility and quality concerns. The FDA issued an "Early Alert" due to potential risks of infection and severe complications, especially for critically ill patients and spinal procedures.

Health Business Science & Technology Medical Science Legal Education AVID Medical Sodium Chloride Medical Device Recall FDA Huons Co., Ltd.Spectra Medical Devices Epidural Kits Food Recalls Drugs
Boston Scientific Recalls Angiographic Catheters Over Tip Detachment Risk

28 Aug 2026 1:58 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Boston Scientific's Imager II Angiographic Catheters, which are being recalled due to a manufacturing defect risking tip detachment. Two serious injuries have been reported, prompting the company to discontinue the product.

Health Business Politics and Government Medical Science Federal Government Legal Boston Scientific Imager II Angiographic Catheters FDA Medical Device Recall Tip Detachment Embolism Early Alert Food Recalls Drugs
Abiomed Recalls Heart Pump Controllers Following Deaths and Injuries

26 Aug 2026 3:21 p.m. · Source: US Food and Drug Administration

Abiomed is recalling Automated Impella Controllers due to purge cassette recognition issues, linked to 37 serious injuries and three deaths. The FDA has issued an Early Alert, advising removal of affected devices.

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FDA Issues Early Alert on AVID Medical Kit Recall Over Fungal Contamination

24 Aug 2026 10:44 a.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding AVID Medical convenience kits, recalled due to fungal contamination from BD ChloraPrep applicators. This contamination poses serious health risks, including infection and death, prompting removal of affected products from use.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues AVID Medical BD ChloraPrep FDA Medical Device Recall Fungal Contamination Aspergillus penicillioides Public Health Food Recalls Drugs
FDA Issues Early Alert for Medline Neonatal Breathing Circuits

21 Aug 2026 4:03 p.m. · Source: US Food and Drug Administration

FDA issues an early alert for Medline neonatal/infant breathing circuits due to electrical connector failures. Risks include airway damage and respiratory distress for infants, though no serious injuries or deaths have been reported as of July 31.

Health Business Science & Technology Medical Science Legal Social Issues Medline FDA Neonatal Breathing Circuits Medical Device Recall Infant Health Electrical Connector Patient Safety Food Recalls Drugs
FDA Issues Early Alert for Becton Dickinson Kits with Recalled Sodium Chloride

18 Aug 2026 5:03 p.m. · Source: US Food and Drug Administration

FDA issues an Early Alert for Becton Dickinson convenience kits containing recalled Huons Co., Ltd. sodium chloride ampules. Patients face infection risks from compromised sterility, though no serious injuries are reported yet.

Health Business Politics and Government USA Medical Science Federal Government Legal Becton Dickinson FDA Medical Device Recall Convenience Kits Sodium Chloride Huons Co., Ltd.Patient Safety Food Recalls Drugs
FDA Alerts Public to Heart Pump Controller Issue from Abiomed

21 May 2026 8:04 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding Abiomed's Automated Impella Controller, which may restart due to a software error, causing a temporary halt in heart pump support for patients. Abiomed has released updated use instructions.

Health Business Science & Technology Politics and Government Medical Science Federal Government Legal Computers and Internet Abiomed Automated Impella Controller AIC Impella FDA Medical Device Recall Product Recall Food Recalls Drugs
Dexcom Recalls Glucose Monitor Receivers Due to Malfunctioning Speakers

17 Jul 2025 3:34 p.m. · Source: US Food and Drug Administration

Dexcom recalls G6, G7, ONE, and ONE+ glucose monitoring receivers because of speaker issues that may cause missed alerts for dangerous blood sugar levels. The FDA has flagged this as a serious recall.

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