MedWatch Safety Alerts

2022 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices

UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers

The FDA is issuing this update to inform the health care community of the final PAS results and updated labeling for the Impella RP System by Abiomed

Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers

The FDA is updating information about Getinge’s Maquet/Datascope IABP devices including information about three voluntary recalls

Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter to Health Care Providers

The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB

2022 Safety Communications

Listing of Medical Device 2022 Safety Communications

Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022

Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium

Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment

The WatchCare IMS includes hospital beds and disposable incontinence pads. Radiofrequency emissions from the system may interfere with other medical devices

2022 Medical Device Recalls

List of Medical Device recalls in 2022

Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

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

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

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication

The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms

Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating

Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating

Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue

Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol

Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain

Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA

La FDA está informando a los pacientes y proveedores de atención médica de que los oxímetros de pulso tienen limitaciones y un riesgo de inexactitud que debe tenerse en cuenta

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

Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs

Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication

The FDA recommends that parents, caregivers, and health care providers not to use infant head shaping pillows to prevent or treat any medical condition

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