The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.
11/8/2019 10:00:00 AM
The detector on the Forte Gamma Camera System has the potential to become detached without warning which could result in a serious injury or death.
11/7/2019 8:00:00 AM
Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.
The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.
Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
11/4/2019 4:25:00 AM
Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.
Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.
ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.
The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX.
Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance
Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup
Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150?, Zantac 150? Cool Mint, and Zantac 75?.
The list below contains recalls that were issued in 2019.
10/8/2019 10:00:00 AM
Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed.
FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries-including some resulting in deaths-following the use of vaping products.
10/4/2019 2:17:00 PM
List of CBER FY 2018 Recall Postings.
10/2/2019 7:15:00 AM
Listing of CBER FY 2019 Recall Postings
10/2/2019 7:15:00 AM
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.
10/1/2019 10:00:00 AM
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication
Mavidon is voluntarily recalling 21 lots of LemonPrep? 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:
Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic fo
- Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride C