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 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots before October 2019 Model 670G (MMT-1780) – all lots before August 2019 Distribution Dates: Model 630G…
GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation
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 GE Carestation 600 series anesthesia systems Model numbers 620/650/650c, A1 Serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002 Manufacturing Dates: August 2018 to July 2019 Distribution Dates:…
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values
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 Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302) Serial numbers: Manufacturing Dates: June 7,…
Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination
Summary Company Announcement Date: January 31, 2020 FDA Publish Date: January 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description due to Microbial Contamination Company Name: Efficient Laboratories, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid Company Announcement Efficient Laboratories, Inc….
Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication
On January 30, 2020, Medtronic released the first round of software updates to address some of the affected devices. Medtronic will issue additional rounds of software updates to address the remaining devices. These software updates will be installed on devices automatically. For more information, see Medtronic’s Security Bulletin. Date Issued March 21, 2019 Audience Patients…
Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve
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 Galemed Babi.Plus® 12.5 cm H2O Pressure Relief Manifold Product code: 2691 Lots: 180806, 180910, 181029, 181105, 181204, 190225, 190327 Distribution Dates: October 2018 to May 2019 Devices…
2020 Medical Device Recalls
The list below contains recalls that were issued in 2020. 2020 Medical Device Recalls Content current as of: 01/29/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/medical-device-recalls/2020-medical-device-recalls
Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication – FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems
[Posted: January 28, 2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly. BACKGROUND: Clozapine affects how…
King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2
Summary Company Announcement Date: January 24, 2020 FDA Publish Date: January 24, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device exhibits a reversed image Company Name: King Systems Brand Name: Brand Name(s) King Vision Product Description: Product Description Laryngoscope Adapter Company Announcement On November 5, 2019, King Systems initiated a voluntary…
2020 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2020 Safety Communications Content current as of: 01/23/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2020-safety-communications