Safety

2017 Safety Alerts for Human Medical Products

Items in the following lists are in alphabetical order. Click "Date Issued" to re-order the items in a list by date. Click "Product Name" to re-order the items alphabetically.

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex 02/24/2017
Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna 01/27/2017
Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions 02/02/2017
HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance 02/15/2017
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter 02/09/2017
PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer 01/12/2017
Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial 01/25/2017

Medical Devices

Product NameDate Issued/Updated
Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error 02/09/2017
Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate 02/16/2017
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use 01/13/2017
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions 01/17/2017
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage 01/30/2017
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified 01/09/2017
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions 01/11/2017
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery 01/14/2017
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action - Particulates Generated in Vial 01/11/2017
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results 01/27/2017

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids 02/09/2017

Products With Undeclared Drug Ingredients

Product NameDate Issued/Updated
XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient 02/22/2017

Page Last Updated: 02/24/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English