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The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
Identify Regulatory TargetSpectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd.
Identify Regulatory TargetThe Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials to the consumer level. The products have been found to be compounded with a Glutathione API containing elevated endot
Identify Regulatory TargetMedical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
Identify Regulatory TargetOn July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect.
Identify Regulatory TargetPatients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
Identify Regulatory TargetRemoval of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.
Identify Regulatory TargetInfinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement.
Identify Regulatory TargetAVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.
Identify Regulatory TargetCertain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
Identify Regulatory TargetMedline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.
Identify Regulatory TargetFOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B.
Identify Regulatory TargetAvid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
Identify Regulatory TargetBoston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism
Identify Regulatory TargetAVID Medical is correcting convenience kits containing Manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall.
Identify Regulatory TargetThe Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc.
Identify Regulatory TargetENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use.
Identify Regulatory TargetAbiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc.
Identify Regulatory TargetCertain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
Identify Regulatory TargetCertain AVID Medical convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
Identify Regulatory TargetThe NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
Identify Regulatory TargetThe cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.
Identify Regulatory TargetAUBURN, Ala. (August 21, 2026) – Vitruvias Therapeutics, Inc.
Identify Regulatory TargetMedical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
Identify Regulatory TargetPatients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
Identify Regulatory TargetMedline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – August 19, 2026 – Houston, Texas, Optimal Balance Pharmacy is voluntarily recalling one lot of Compounded Glutathione 200 MG/ML 30 ML Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels.
Identify Regulatory TargetMedline is correcting affected convenience kits by removing included B. Braun components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B.
Identify Regulatory TargetBD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
Identify Regulatory TargetBD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
Identify Regulatory TargetBaxter 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.
Identify Regulatory TargetMedline is correcting affected convenience kits by removing included ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
Identify Regulatory TargetCertain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – August 10, 2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to cont
Identify Regulatory TargetThe ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
Identify Regulatory TargetAbiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
Identify Regulatory TargetOn July 13, 2026, Medline Industries, LP initiated a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. Medline received reports of sporadic failures involving the electrical connector of certain neonatal and infant heated wire breathing circuits.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syri
Identify Regulatory TargetFOR IMMEDIATE RELEASE – August 5, 2026 – Austin, Texas, Victory Medical Center Pharmacy is voluntarily recalling certain lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin leve
Identify Regulatory TargetFOR 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 the user level (hospitals, imaging center
Identify Regulatory TargetBD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – July 31, 2026 – Shirley, NY, American Regent, Inc. Animal Health is conducting a nationwide recall of two lots (25011 and 3369) of Adequan® Canine Injection (for dogs), 100 mg/mL 5mL multi-dose vials and two lots (24416 and 25265P) of Adequan® i.m.
Identify Regulatory TargetParticulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Identify Regulatory TargetMedline is correcting affected convenience kits by removing recalled Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection components from affected convenience kits.
Identify Regulatory TargetFRANKLIN LAKES, N.J. (July 31, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling specific lots of BD® Intraosseous Vascular Access System Needle Sets to the user level. These products are being recalled following reports that some users experienced difficulty removing the obturato
Identify Regulatory TargetFailure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death.
Identify Regulatory TargetArgon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
Identify Regulatory TargetJuly 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level.
Identify Regulatory TargetJuly 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this pa
Identify Regulatory TargetENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
Identify Regulatory TargetJuly 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard. Risk Statement: The use of the defective product has a
Identify Regulatory TargetJuly 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard.Risk Statement: The use of the defective product has a
Identify Regulatory TargetBaxter 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.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J.
Identify Regulatory TargetAffected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
Identify Regulatory TargetProlonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.
Identify Regulatory TargetSaline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
Identify Regulatory TargetB. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
Identify Regulatory TargetFailure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
Identify Regulatory TargetVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
Identify Regulatory TargetThe distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
Identify Regulatory TargetParticulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Identify Regulatory TargetCertain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
Identify Regulatory TargetA software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
Identify Regulatory TargetIf dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
Identify Regulatory TargetCertain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
Identify Regulatory TargetThe ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
Identify Regulatory TargetSpecific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
Identify Regulatory TargetCertain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.
Identify Regulatory TargetBioZorb Markers are implantable and used to mark soft tissue for procedures. They are being recalled after reports of patient complications.
Identify Regulatory TargetNorth American Rescue is correcting first aid kits that contain blood glucose monitors affected by Trividia’s TRUE METRIX recall
Identify Regulatory TargetA software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
Identify Regulatory TargetThe air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
Identify Regulatory TargetAbiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
Identify Regulatory TargetCertain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis
Identify Regulatory TargetCertain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile
Identify Regulatory TargetThe FDA issued a LHCP to notify providers that Stereotactic Breast Biopsy Needles (product code KNW) are experiencing a supply disruption.
Identify Regulatory TargetDraeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.
Identify Regulatory TargetMedline is correcting affected convenience kits by removing recalled Bupivacaine Hydrochloride in Dextrose Injection components.
Identify Regulatory TargetFOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level.
Identify Regulatory TargetRead the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
Identify Regulatory TargetVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
Identify Regulatory TargetCertain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
Identify Regulatory TargetThe FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using
Identify Regulatory TargetThe ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation
Identify Regulatory TargetFRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level.
Identify Regulatory TargetThe air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
Identify Regulatory TargetGE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.
Identify Regulatory TargetCertain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.
Identify Regulatory TargetWARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.
Identify Regulatory TargetBD is correcting affected Spinal Trays by removing Bupivacaine ampule components
Identify Regulatory TargetLearn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
Identify Regulatory TargetListing of Medical Device 2024 Safety Communications
Identify Regulatory Target