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November 15, 2022 at 12:00 AM
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 with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin M
November 07, 2022 at 12:00 AM
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
November 07, 2022 at 12:00 AM
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 undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Persons who accidently ingest (
November 05, 2022 at 12:00 AM
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) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies.
November 04, 2022 at 12:00 AM
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-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for
November 03, 2022 at 12:00 AM
The FDA recommends that parents, caregivers, and health care providers not to use infant head shaping pillows to prevent or treat any medical condition.
November 03, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
November 02, 2022 at 12:00 AM
The Iso-Gard Filter S is a breathing circuit bacterial filter. It may split or detach preventing patients from getting sufficient supply of air.
November 01, 2022 at 12:00 AM
The FDA posts letters to health care providers about the safe use of medical devices.
November 01, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
November 01, 2022 at 12:00 AM
The Iso-Gard Filter S is a breathing circuit bacterial filter. It may split or detach preventing patients from getting sufficient supply of air.
October 31, 2022 at 12:00 AM
The FDA posts letters to health care providers about the safe use of medical devices.
October 31, 2022 at 12:00 AM
The FDA recommends health care providers discuss alternatives for MRI-guided breast biopsies with patients due to shortage of Philips Invivo plates and disposables.
October 31, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
October 31, 2022 at 12:00 AM
The FDA recommends using the following strategies to reduce the number of tracheostomy tubes used per patient during the shortage.
October 28, 2022 at 12:00 AM
The FDA posts letters to health care providers about the safe use of medical devices.
October 28, 2022 at 12:00 AM
The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
October 25, 2022 at 12:00 AM
East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N
October 25, 2022 at 12:00 AM
Do not to use the recalled Mighty Bliss electric heating pads due to the risks of injury, including electric shocks, skin burns, rashes or irritation.
October 25, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
October 25, 2022 at 12:00 AM
Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass pa
October 24, 2022 at 12:00 AM
Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare system is designed to discreetly alert the caregiver of an inc
October 24, 2022 at 12:00 AM
Boston, MA, October 18, 2022 / PRNewswire / – Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation
October 19, 2022 at 12:00 AM
Certain Philips masks can cause potential injury or death if magnets interfere with certain implanted metallic medical devices or metallic objects in the body.
October 19, 2022 at 12:00 AM
Certain Philips Respironics masks for BiPAP and CPAP machines are recalled due to a risk that their magnetic clips may interact with other medical devices.