U.S. Food & Drug Administration · October 6, 2026
- Affected product
- Nova Biomedical StatStrip StatStrip Glucose Hospital Meter System
- Category
- Medical device recalls
- Hazard
- Software issue may cause a glucose result to be associated to the wrong patient
Check affected Nova Biomedical StatStrip StatStrip Glucose Hospital Meter System identifiers →U.S. Food & Drug Administration · September 8, 2026
- Affected product
- BMC Luna G3 APAP (Model LG3600)
- Category
- Medical device recalls
- Hazard
- The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect
Check affected BMC Luna G3 APAP (Model LG3600) identifiers →FDA MedWatch · September 3, 2026
- Affected product
- Early Alert: Breathing Circuit from Draeger
- Category
- Medical device recalls
- Hazard
- Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.
Check affected Early Alert: Breathing Circuit from Draeger identifiers →FDA MedWatch · September 3, 2026
- Affected product
- Monitoring System Correction: GE HealthCare Updates Use Instructions
- Category
- Medical device recalls
- Hazard
- Patients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
Check affected Monitoring System Correction: GE HealthCare Updates Use Instructions identifiers →FDA MedWatch · August 28, 2026
- Affected product
- Early Alert: Angiographic Catheter from Boston Scientific
- Category
- Medical device recalls
- Hazard
- Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism
Check affected Early Alert: Angiographic Catheter from Boston Scientific identifiers →FDA MedWatch · August 24, 2026
- Affected product
- Early Alert: Nitric Oxide Delivery System from NOxBOX
- Category
- Medical device recalls
- Hazard
- The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
Check affected Early Alert: Nitric Oxide Delivery System from NOxBOX identifiers →FDA MedWatch · August 24, 2026
- Affected product
- Early Alert: Ventilator from CooperSurgical
- Category
- Medical device recalls
- Hazard
- The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.
Check affected Early Alert: Ventilator from CooperSurgical identifiers →FDA MedWatch · August 24, 2026
- Affected product
- Early Alert: Convenience Kit from AVID Medical
- Category
- Medical device recalls
- Hazard
- Certain AVID Medical convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
Check affected Early Alert: Convenience Kit from AVID Medical identifiers →FDA MedWatch · August 24, 2026
- Affected product
- Early Alert: Convenience Kit from Medline
- Category
- Medical device recalls
- Hazard
- Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
Check affected Early Alert: Convenience Kit from Medline identifiers →FDA MedWatch · August 21, 2026
- Affected product
- Early Alert: Portrait Core Services Software from GE HealthCare
- Category
- Medical device recalls
- Hazard
- Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
Check affected Early Alert: Portrait Core Services Software from GE HealthCare identifiers →FDA MedWatch · August 21, 2026
- Affected product
- Early Alert: Epidural Kit from Medical Action Industries
- Category
- Medical device recalls
- Hazard
- Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
Check affected Early Alert: Epidural Kit from Medical Action Industries identifiers →FDA MedWatch · August 21, 2026
- Affected product
- Early Alert: Breathing Circuit from Medline
- Category
- Medical device recalls
- Hazard
- Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.
Check affected Early Alert: Breathing Circuit from Medline identifiers →FDA MedWatch · August 20, 2026
- Affected product
- Convenience Kit : Medline Correction for Convenience Kits Containing
- Category
- Medical device recalls
- Hazard
- Medline is correcting affected convenience kits by removing included B. Braun components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
Check affected Convenience Kit : Medline Correction for Convenience Kits Containing identifiers →FDA MedWatch · August 18, 2026
- Affected product
- Early Alert: Convenience Kit from Becton Dickinson
- Category
- Medical device recalls
- Hazard
- BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
Check affected Early Alert: Convenience Kit from Becton Dickinson identifiers →FDA MedWatch · August 17, 2026
- Affected product
- Intraosseous Needle Set : Becton Dickinson Removes Certain
- Category
- Medical device recalls
- Hazard
- BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
Check affected Intraosseous Needle Set : Becton Dickinson Removes Certain identifiers →FDA MedWatch · August 13, 2026
- Affected product
- Intravascular Administration Set : Baxter Removes Duo-Vent Solution
- Category
- Medical device recalls
- Hazard
- Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.
Check affected Intravascular Administration Set : Baxter Removes Duo-Vent Solution identifiers →FDA MedWatch · August 12, 2026
- Affected product
- Convenience Kit Correction: Medline Correction for Convenience Kits
- Category
- Medical device recalls
- Hazard
- Medline is correcting affected convenience kits by removing included ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
Check affected Convenience Kit Correction: Medline Correction for Convenience Kits identifiers →FDA MedWatch · August 12, 2026
- Affected product
- Update on Alert: Convenience Kit from Medline
- Category
- Medical device recalls
- Hazard
- Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
Check affected Update on Alert: Convenience Kit from Medline identifiers →FDA MedWatch · August 11, 2026
- Affected product
- Breathing Circuit Set : Hamilton Medical Removes Breathing Circuit
- Category
- Medical device recalls
- Hazard
- The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
Check affected Breathing Circuit Set : Hamilton Medical Removes Breathing Circuit identifiers →FDA MedWatch · August 10, 2026
- Affected product
- Join SBIA for Two Upcoming FDA Webinars on U.S. Prescribing
- Category
- Medical device recalls
- Hazard
- Receive this email as a forward? Subscribe to CDER SBIA industry updates. CDER | Small Business and Industry Assistance (SBIA) Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information September 23, 2026 | 1:00 p.m. - 3:00 p.m. ET…
Check affected Join SBIA for Two Upcoming FDA Webinars on U.S. Prescribing identifiers →FDA MedWatch · August 10, 2026
- Affected product
- Catheter Introducer Correction: Abiomed and Oscor Correction for
- Category
- Medical device recalls
- Hazard
- Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
Check affected Catheter Introducer Correction: Abiomed and Oscor Correction for identifiers →U.S. Food & Drug Administration · August 5, 2026
- Affected product
- Fresenius Kabi of One Lot of Morphine Sulfate Injection, USP in a
- Category
- Medical device recalls
- Hazard
- FDA
Check affected Fresenius Kabi of One Lot of Morphine Sulfate Injection, USP in a identifiers →FDA MedWatch · August 4, 2026
- Affected product
- Liebel-Flarsheim , LLC of OPTIRAY Imaging Bulk Package - 350, 500mL
- Category
- Medical device recalls
- Hazard
- FOR IMMEDIATE RELEASE – July 31, 2026 – Raleigh, North Carolina, Liebel-Flarsheim Company, LLC, is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to…
Check affected Liebel-Flarsheim , LLC of OPTIRAY Imaging Bulk Package - 350, 500mL identifiers →U.S. Food & Drug Administration · December 26, 2025
- Affected product
- Multiple brand names All FDA-regulated products held at facility including drugs,
- Category
- Food recalls, Pet food recalls, Medical device recalls
- Hazard
- Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process.
Check affected Multiple brand names All FDA-regulated products held at facility including drugs, identifiers →FDA MedWatch · September 29, 2025
- Affected product
- What is an Early Alert?
- Category
- Medical device recalls
- Hazard
- Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication
Check affected What is an Early Alert? identifiers →
