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FDA MedWatch

Clinically important safety information regarding human medical products
November 29, 2023 at 12:00 AM
Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil
E. Hampton NY- Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products f
November 29, 2023 at 12:00 AM
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers
Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices.
November 28, 2023 at 12:00 AM
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
Reports of smoke, sparks, fire, and burns stemming from use of the DreamStation2 CPAP machines prompt warning from the FDA.
November 28, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
November 28, 2023 at 12:00 AM
BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication - FDA Investigating Serious Risk of T-cell Malignancy
The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
November 28, 2023 at 12:00 AM
Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication - FDA Warns of Rare but Serious Drug Reaction
The FDA is warning that the antiseizure medicines can cause a rare but serious reaction, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that can be life-threatening if not diagnosed and treated quickly.
November 27, 2023 at 12:00 AM
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
Unomedical A/S is recalling their Varisoft infusion set due to the connector detaching more easily than expected, thereby interrupting the delivery of insulin.
November 27, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
November 27, 2023 at 12:00 AM
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identifi
November 24, 2023 at 12:00 AM
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third- party lab found that samples fr
November 21, 2023 at 12:00 AM
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.
November 21, 2023 at 12:00 AM
Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
November 21, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
November 21, 2023 at 12:00 AM
Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil
Miami Gardens, Florida, Noah’s Wholesale, LLC is voluntarily recalling one lot of the rock# 03032021,exp:12/2027,1200 mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found
November 20, 2023 at 12:00 AM
2023 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
November 20, 2023 at 12:00 AM
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps.
November 17, 2023 at 12:00 AM
B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
B. Braun Medical, Inc. recalls Infusomat Space Volumetric Infusion Pump System, used by trained healthcare professionals, due to faulty occlusion alarms
November 17, 2023 at 12:00 AM
B. Braun Medical, Inc. Recalls Infusomat® Space® Large Volume Pump, Wireless and Infusomat® Space® Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
B. Braun Medical, Inc. recalls Infusomat® Space Volumetric Infusion Pump System, used by trained healthcare professionals, due to faulty occlusion alarms
November 17, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
November 17, 2023 at 12:00 AM
KinderFarms, LLC Voluntarily Recalling all KinderMed Pain & Fever Products Due to Acetaminophen Instability
– KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products were manufa
November 16, 2023 at 12:00 AM
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
November 16, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
November 16, 2023 at 12:00 AM
Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
Asensus Surgical Inc. is recalling the Senhance Surgical System, used in laparoscopic procedures, due to malfunctions and needing a software update.
November 15, 2023 at 12:00 AM
Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
The Novum IQ syringe pump, intended to be used for the controlled administration of fluids, is being recalled due to downstream occlusion false alarms.
November 15, 2023 at 12:00 AM
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
Sanxin Single Use Syringes are used for hemodialysis treatments. They are recalled for blood or heparin solution leaking from the syringe.
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