MedWatch Safety Alerts

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

Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency

Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial

2021 Medical Device Recalls

List of Medical Device recalls in 2021

Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia

Certain canisters of AMBSORB PLUS used to absorb carbon dioxide during anesthesia may cause difficulties in gas flow, resulting in reduced flow to patients.

Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge

This catheter is used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media.

Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device

Pipeline Flex Embolization Devices are intended to treat wide-neck and fusiform brain aneurysms. Pieces of the delivery system may break off while in use.

IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance

Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two

Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers

False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or

Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers

The FDA is alerting health care providers about the use of certain fluid warmers and the potential for aluminum leaching

2021 Biologics Recalls

Listing of the 2021 Biologics Recalls

Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set

Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer and Level 1® Normothermic I.V. Fluid Administration Set manufactured by Smiths Medical ASD Inc

Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

Smiths Medical ASD Inc is recalling the NORMOFLO Irrigation Fluid Warmer and Warmers Sets because of the potential for aluminum ions leaching into warmed fluids

Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination

Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been

Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum

When used for warming therapy, the Recirculator 8.0 Disposable Lavage Kit from Eight Medical may expose patients to high levels of aluminum

Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers

Ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

The recall is due to issues with PE-PUR foam, used to reduce sound and vibration, breaking down and potentially entering the device’s air pathway

Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination

Do not use ultrasound gels and lotions manufactured by Eco-Med, as these products are at risk for bacterial contamination

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit

Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“

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