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Public Health Notifications

The following Web Notifications represents a new form of Notification for CDRH.Web Notifications are intended to augment the existing Safety Notification program and provide a mechanism to quickly disseminate device–related safety information beneficial to healthcare providers, but not appropriate for our existing forms of Notifications.Web notifications may be used in instances where the available information is limited, changing, and/or the Center may not be able to make specific recommendations, but would like to provide the information that we have to the healthcare community in a timely fashion.Web Notifications will be updated as additional information becomes available so you are encouraged to check back at this site.

Date Issued


Web Notification 11/25/2003
Updated October 18, 2004
Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent Text PDF
Web Notification 12/19/2003
Updated May 7, 2004
Counterfeit Polypropylene Mesh Text PDF
Web Notification 10/31/2002
Updated May 7, 2004
Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine Text PDF
Web Notification 10/23/2002 Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription Text PDF

Web Notification


Risk of Bacterial Meningitis in Children with Cochlear Implants Text PDF


Date Issued
Public Health Notification 4/2/2004 Paralysis from Absorbable Hemostatic Agent Text PDF
Public Health Notification 12/18/2003
Updated 3/30/2004
Safety Tips for Preventing Hospital Bed Fires Text PDF
Public Health Notification 12/17/2003 Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System
Text PDF
Public Health Notification 12/19/2002 Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
Text PDF
Notice 7/12/2002 PVC Devices Containing the Plasticizer DEHP Text PDF
Notice 11/2/2001 Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients Text PDF
Public Health Advisory 7/20/2001 Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels Text PDF
Notice 4/27/2001 Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA) Text PDF
Notice 3/13/2001 Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers Text PDF
Notice 10/11/2000 Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia Text PDF
Notice 8/29/2000 Potential for Injury from Circumcision Clamps Text PDF
Public Health Advisory 7/10/2000 Risk of Electromagnetic Interference with Medical Telemetry Systems Text PDF
Notice 10/8/1999 Complications Related to the Use of Vascular Hemostasis Devices   Text PDF
Public Health Advisory 9/10/99 Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System Text PDF
Safety Alert 5/11/99 Potential Cross-Contamination Linked to Hemodialysis Treatment Text  
Notice 5/4/99 Hypotension and Bedside Leukocyte Reduction Filters Text  
Advisory 2/22/99 Glass Capillary Tubes: Joint Safety Advisory About Potential Risks Text  
Advisory 2/4/99 Explosions and Fires in Aluminum Oxygen Regulators Text  
Advisory 12/29/98 FDA Medical Device Malfunction Text  
Notice 10/8/98 NIR ON Ranger w/SOX Premounted Stent System Text  
Notice 9/28/98 Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators Text  
Notice 9/25/98 Illegal Promotion of Contact Lenses   Text PDF
Notice 8/3/98 Electrical Hazards Associated With Lead Wires and Cables Text  
Public Health Advisory 5/21/98 Need for CAUTION When Using Vacuum Assisted Delivery Devices Text  
Safety Alert 4/13/98 Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System Text  
Public Health Advisory 3/20/98 Interference Between Digital TV Transmissions and Medical Telemetry Systems Text  
Notice 3/13/98 Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices Text  
Safety Alert 3/12/98 Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera Text  
Notice 2/13/98 Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera Text  
Notice 10/16/97 Update to Radioactivity in Radiation Protection Devices Text  
Notice 8/13/97 Vacuum Loss in Electronic Resonating Components Text  
Notice 8/5/97 Update to Radioactivity in Radiation Protection Devices Text  
Public Health Advisory 7/25/97 Limitations of Toxoplasma IgM Commercial Test Kits Text  
Public Health Advisory 7/7/97 Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease Text  
Notice 6/13/97 Radioactivity in Radiation Protection Devices
(8/5/97 and 10/16/97 Updates to Notice)
Notice 5/21/97 Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses Text  
Notice 4/17/97 Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities Text  
Safety Alert 3/24/97 Risks of Devices for Direct Detection of Group B Streptococcal Antigen Text  
Notice 12/16/96 Important Information Relating to Cellulose Acetate Dialyzers Text  
Notice 10/10/96 Dear Manufacturers and Users of Lasers for Refractive Surgery  Text  
Public Health Advisory 6/27/96 Potential Risk of Spontaneous Combustion in Large Quantities of Patient-Examination Gloves Text  
Public Health Advisory 12/12/95 Hazards Associated With The Use of Electric Heating Pads    PDF
Public Health Advisory 10/16/95 Retinal Photic Injuries From Operating Microscopes During Cataract Surgery Text  
Safety Alert 8/23/95 Entrapment Hazards With Hospital-Bed Side Rails Text  
Notice 7/15/94 Important Information About TMJ Implants    PDF
Public Health Advisory 9/30/94 Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically Guided Procedures Text  
Safety Alert 4/18/94 Hazards of Precipitation Associated With Parenteral Nutrition    PDF
Public Health Advisory 3/1/94 Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices    PDF
Public Health Advisory 2/28/94 Occluded Endotracheal Tubes    PDF
Public Health Advisory 12/28/93 Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices    PDF
Safety Alert 9/3/93 Unsafe Patient Lead Wires and Cables   PDF
Safety Alert 9/15/93 Hazards of Volume Ventilators and Heated Humidifiers     PDF

For copies of documents dated earlier than 1994, contact Dolly Wilson, ( or fax 301-594-2968. Please provide your name, mailing address or fax number, and the title of the document you are requesting.

Safety Alert 8/19/93 Fluoride Contamination of Hemodialysis Water Supply
Safety Alert 7/14/93 Hazards of Heated-Wire Breathing Circuits
Safety Alert 11/25/92 MRI-Related Death of Patient With Aneurysm Clip
Notice 10/23/92 Important Information About New Studies on Dialyzer Germicides
Notice 8/20/92 Important Information About Rophae Intraocular Lenses
Safety Alert 7/15/92 Potential Hazards With Restraint Devices
Safety Alert 5/29/92 Caude Equina Syndrome - Use of Catheters
Safety Alert 5/20/92 Aluminum and Other Trace-Element Contamination in Dialysis Facilities
Notice 4/21/92 Important Information on Shiley CC Valve Fractures
Safety Alert 4/16/92 Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V.
Safety Alert 3/6/92 Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes
Public Health Advisory 9/91 Vitek Proplast Temporomandibular Joint Implants
Safety Alert 12/28/90 Serious Problems With Proplast-Coated TMJ Implant
Public Health Advisory 8/28/90 Hepatitis B Transmission Via Spring-Loaded Lancet Devices
Public Health Advisory 5/11/90 Gas/Air Embolism Associated With Intrauterine Laser Surgery
Public Health Advisory 2/16/90 Important Tips for Apnea Monitor Users
Notice 5/30/89 New FDA Recommendations & Results of Contact Lens Study
Safety Alert 3/15/89 Sodium Azide Contamination of Hemodialysis Water Supplies
Safety Alert 1/24/89 Homemade Saline Solutions for Lenses
Safety Alert 2/19/88 Chloramine Contamination of Hemodialysis Water Supplies
Safety Alert 4/28/87 Possibly Contaminated Dura Mater
Notice 6/19/85 Apnea Monitors
Safety Alert 3/28/85 Defibrillator Batteries
Safety Alert 2/7/84 Pediatric Cribs
Safety Alert 11/3/83 Dialyzer: First-Use Syndrome
Safety Alert 9/2/83 Breathing System Connectors
Safety Alert 6/16/83 Electrically Powered Hospital Beds

Other Resources

Updated October 27, 2004

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