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Public Health Notifications

A Public Health Notification is an important message from the FDA’s Center for Devices and Radiological Health to the health care community describing a risk associated with the use of a medical device and providing recommendations to avoid or reduce the risk.

A Preliminary Public Health Notification is similar to a Public Health Notification. However, it is issued when the information we have is still evolving, but we believe that the health care community needs this early information to make informed clinical decisions. When we issue a Preliminary Public Health Notification, we intend to update it as important information or new recommendations become available.

We encourage readers to subscribe to email updates to receive email announcements when a new or revised Public Health Notification or Preliminary Public Health Notification is issued.

Also available: information on recalls, Archived Public Health Notifications, and additional FDA safety information from MedWatch.

Date Issued Title


10/20/2008 Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Text  
9/24/2008 Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status Text  
7/14/2008 Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning Text  
7/1/2008 Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Text  
3/17/2008 Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System Text  

Denture Cleanser Allergic Reactions and Misuse

See Related Document: Advice to Patients

1/15/2008 Unretrieved Device Fragments Text  
12/12/2007 Patient Burns from Electric Dental Handpieces Text  
12/4/2007 Vail Products Enclosed Bed Systems Text  

Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment


Importance of Vaccination in Cochlear Implant Recipients

See Related Document: Advice to Patients

8/13/2007 Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps

Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.

See Related Document: Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety (7/24/2007)

See Related Document: Public Health Advisory: Hazards Associated With The Use of Electric Heating Pads
(NOTE: Although this Advisory was released in 1995, the recommendations are still valid.)


Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO)

See Related Document: Advice to Patients


Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.

See Related Document: Advice to Patients


Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change

See Related Document: Advice to Patients

Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector Text  
2/1/2007 Precautions in Using the Reintroduced Vapotherm® 2000i [Respiratory Gas Humidifier] System Text  
Updated 6/22/2006
Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures Text  
Updated 6/19/2006
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals Text  
Updated 5/31/2006

Fungal Keratitis Infections Related to Contact Lens Use

See Related Document: Advice to Patients

2/27/2006 Update: Gambro Prisma® Continuous Renal Replacement System Text  

Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond Twenty-Four Months Post-Implantation

See Related Document: Advice to Patients


Second Update: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

11/16/2005 Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands Text  

(See 12/28/05 Update)

Update: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

7/29/2005 Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders Text  
(See 12/28/05 Update)

Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

Updated 10/18/2004
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  
Updated 6/24/2005
Vail Products Enclosed Bed Systems Text  
5/10/2005 MRI-Caused Injuries in Patients with Implanted Neurological Stimulators Text  
Updated 5/7/2004
Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine Text  
Updated 5/7/2004
Counterfeit Polypropylene Mesh Text  
4/2/2004 Paralysis from Absorbable Hemostatic Agent Text  
Updated 3/30/2004
Safety Tips for Preventing Hospital Bed Fires Text  
12/17/2003 Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System
12/19/2002 Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
10/23/2002 Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription Text  
7/12/2002 PVC Devices Containing the Plasticizer DEHP Text  
11/2/2001 Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients Text  
7/20/2001 Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels Text  
4/27/2001 Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA) Text  
3/13/2001 Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers Text  
10/11/2000 Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia Text  
8/29/2000 Potential for Injury from Circumcision Clamps Text  
7/10/2000 Risk of Electromagnetic Interference with Medical Telemetry Systems Text  
10/8/1999 Complications Related to the Use of Vascular Hemostasis Devices   Text  
9/10/99 Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System Text  
5/11/99 Potential Cross-Contamination Linked to Hemodialysis Treatment Text  
5/4/99 Hypotension and Bedside Leukocyte Reduction Filters Text  
2/22/99 Glass Capillary Tubes: Joint Safety Advisory About Potential Risks Text  
2/4/99 Explosions and Fires in Aluminum Oxygen Regulators Text  
10/8/98 NIR ON Ranger w/SOX Premounted Stent System Text  
9/28/98 Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators Text  
9/25/98 Illegal Promotion of Contact Lenses   Text  
8/3/98 Electrical Hazards Associated With Lead Wires and Cables Text  
5/21/98 Need for CAUTION When Using Vacuum Assisted Delivery Devices Text  
4/13/98 Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System Text  
3/20/98 Interference Between Digital TV Transmissions and Medical Telemetry Systems Text  
3/13/98 Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices Text  
3/12/98 Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera Text  
2/13/98 Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera Text  
8/13/97 Vacuum Loss in Electronic Resonating Components Text  
7/25/97 Limitations of Toxoplasma IgM Commercial Test Kits Text  
7/7/97 Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease Text  
5/21/97 Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses Text  
4/17/97 Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities Text  
3/24/97 Risks of Devices for Direct Detection of Group B Streptococcal Antigen Text  
12/16/96 Important Information Relating to Cellulose Acetate Dialyzers Text  
10/10/96 Dear Manufacturers and Users of Lasers for Refractive Surgery  Text  
6/27/96 Potential Risk of Spontaneous Combustion in Large Quantities of Patient-Examination Gloves Text  
12/12/95 Hazards Associated With The Use of Electric Heating Pads    PDF
10/16/95 Retinal Photic Injuries From Operating Microscopes During Cataract Surgery Text  
8/23/95 Entrapment Hazards With Hospital-Bed Side Rails Text  
7/15/94 Important Information About TMJ Implants    PDF
9/30/94 Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically Guided Procedures Text  
4/18/94 Hazards of Precipitation Associated With Parenteral Nutrition    PDF
3/1/94 Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices    PDF
2/28/94 Occluded Endotracheal Tubes    PDF
12/28/93 Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices    PDF
9/15/93 Hazards of Volume Ventilators and Heated Humidifiers     PDF
9/3/93 Unsafe Patient Lead Wires and Cables   PDF
8/19/93* Fluoride Contamination of Hemodialysis Water Supply   PDF
7/14/93 Hazards of Heated-Wire Breathing Circuits   PDF
11/25/92 MRI-Related Death of Patient With Aneurysm Clip   PDF
10/23/92 Important Information About New Studies on Dialyzer Germicides   PDF
7/15/92 Potential Hazards With Restraint Devices   PDF
5/29/92 Caude Equina Syndrome - Use of Catheters   PDF
5/20/92 Aluminum and Other Trace-Element Contamination in Dialysis Facilities   PDF
4/21/92 Important Information on Shiley CC Valve Fractures   PDF
4/16/92 Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V.   PDF
3/6/92 Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes   PDF
9/91 Vitek Proplast Temporomandibular Joint Implants   PDF
12/28/90 Serious Problems With Proplast-Coated TMJ Implant   PDF
8/28/90 Hepatitis B Transmission Via Spring-Loaded Lancet Devices   PDF
5/11/90 Gas/Air Embolism Associated With Intrauterine Laser Surgery   PDF
2/16/90 Important Tips for Apnea Monitor Users   PDF
5/30/89 New FDA Recommendations & Results of Contact Lens Study   PDF
3/15/89 Sodium Azide Contamination of Hemodialysis Water Supplies   PDF
1/24/89 Homemade Saline Solutions for Lenses   PDF
2/19/88 Chloramine Contamination of Hemodialysis Water Supplies   PDF
4/28/87 Possibly Contaminated Dura Mater   PDF
6/19/85 Apnea Monitors   PDF
3/28/85 Defibrillator Batteries   PDF
11/30/83 Dialyzer: First-Use Syndrome   PDF
9/2/83 Breathing System Connectors   PDF
6/16/83 Electrically Powered Hospital Beds   PDF

Updated October 21, 2008

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