Date Issued: January 18, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP)….
Risks with Exactech Equinoxe Shoulder System with Defective Packaging – FDA Safety Communication
314-01-02 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small 10885862084408 314-01-03 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium 10885862084415 314-01-04 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large 10885862084422 314-01-12 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small 10885862084439 314-01-13 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53…
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Regard Operative Lap P&S Surgical Kit Product Codes: LRO – See Recall Database…
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Tracheostomy Care Kit, Dressing Change Kit, and Tracheostomy Care Set Product Codes: NXA, MCY – See Recall Database Entry: Model Numbers: Catalog No. 800 TRACHEOSTOMY…
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Ivenix Large Volume Pump Product Codes: FRN Model Numbers: LVP-0004 Distribution Dates: October 1, 2021 to July 31, 2023 Devices Recalled in the U.S.: 938…
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: AirFit and AirTouch masks Product Codes: See Recall Database Entries: Model Numbers: AirFit…
Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication – Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
[Posted 01/11/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. FDA’s…
Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Omnipod 5 App (on compatible Android smartphones) Product Codes: QFG Software Version…
Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal…
Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers
January 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the EVair or EVair 03 (Jun-air) compressors are used with certain ventilators. Compressors are optional accessories for ventilators…