Archived Content

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Medical Devices

Archived Public Health Notifications

A Public Health Notification was an important message 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.  They were published until 2009 when they were replaced with Safety Communications

Please see the Safety Communication section for the most current Medical Device Safety information. 

Also available: information on recalls and additional FDA safety information from MedWatch.


 

The following documents have been designated "Archived" because they were released over 2 years ago or because they have been updated with new information.

Archive: 2009

TitleDate
FDA Preliminary Public Health Notification*: Serious Complications Associated with Negative Pressure Wound Therapy Systems [ARCHIVED] 11/13/2009
FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ* Glucose Monitoring Technology [ARCHIVED] 8/13/2009
Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings [ARCHIVED]

Archive: 2008

TitleDate
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence [ARCHIVED] 10/20/2008
FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status [ARCHIVED] 9/24/2008
FDA Preliminary Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning [ARCHIVED] 7/14/2008
FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion [ARCHIVED] 7/1/2008
FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System [ARCHIVED] 3/17/2008
FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse [ARCHIVED] 2/25/2008
FDA Public Health Notification: Unretrieved Device Fragments [ARCHIVED] 1/15/2008

Archive: 2007

TitleDate
FDA Public Health Notification: Patient Burns from Electric Dental Handpieces [ARCHIVED] 12/12/2007
FDA Public Health Notification: Deaths reported following Radio Frequency Ablation of Lung Tumors [ARCHIVED] 12/11/07
Public Health Notification from FDA: Vail Products Enclosed Bed Systems [ARCHIVED] 12/4/2007
Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment [ARCHIVED] 10/31/2007
FDA Public Health Notification: Importance of Vaccination in Cochlear Implant Recipients [ARCHIVED] 10/10/2007
FDA Preliminary Public Health Notification: Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps [ARCHIVED] 8/13/2007
Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety [ARCHIVED] 7/25/2007
FDA Preliminary Public Health Notification: Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO) [ARCHIVED] 5/31/2007
FDA Preliminary Public Health Notification*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc. [ARCHIVED] 5/18/2007
FDA Preliminary Public Health Notification*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc. (archived) [ARCHIVED] 4/18/07
FDA Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change [ARCHIVED] 3/1/2007
FDA Public Health Notification: Custom Ultrasonics, Inc. Endoscope Washer/Disinfectors [ARCHIVED] 2/27/07
FDA Public Health Notification: Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector [ARCHIVED] 7/19/2007
FDA Public Health Notification: Precautions in Using the Reintroduced Vapotherm®> 2000i [Respiratory Gas Humidifier] System [ARCHIVED] 2/1/2007

Archive: 2006

TitleDate
FDA Public Health Notification: Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures [ARCHIVED] 6/22/2006
FDA AND NIOSH Public Health Notification: Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals [ARCHIVED] 6/19/2006
FDA Public Health Notification: Fungal Keratitis Infections Related to Contact Lens Use [ARCHIVED] 5/31/2006
FDA Preliminary Public Health Notification: Important Safety Recommendations for Baxter's COLLEAGUE Infusion Pumps [ARCHIVED] 4/28/06
FDA AND NIOSH Public Health Notification: Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals (archived) [ARCHIVED] 4/24/06
Preliminary Public Health Notification - Fungal Keratitis Infections Related to Contact Lens Use (2nd archival) [ARCHIVED] 4/21/06
Preliminary Public Health Notification - Fungal Keratitis Infections Related to Contact Lens Use (1st archival) [ARCHIVED] 4/10/06
FDA Updated Public Health Notification: Gambro Prisma® Continuous Renal Replacement System [ARCHIVED] 2/27/2006
FDA Public Health Notification: Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond Twenty-Four Months Post-Implantation [ARCHIVED] 2/6/2005

Archive: 2001-2005

TitleDate
Second Update of FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators [ARCHIVED] 12/28/05
FDA Preliminary Public Health Notification*: Update of Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device [ARCHIVED] 12/20/05
FDA Public Health Notification: Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands [ARCHIVED] 11/16/05
FDA Preliminary Public Health Notification*: New Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device [ARCHIVED] 10/27/05
FDA Preliminary Public Health Notification*: Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD) [ARCHIVED] 10/14/05
Update of FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators [ARCHIVED] 10/13/05
FDA Preliminary Public Health Notification*: Gambro Prisma® Continuous Renal Replacement System [ARCHIVED] 8/23/05
FDA Public Health Notification: Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders [ARCHIVED] 7/29/05
FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators [ARCHIVED] 7/14/05
FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators [ARCHIVED] 5/10/05
FDA Preliminary Public Health Notification*: Vail Products Enclosed Bed Systems [ARCHIVED] 3/25/05
FDA Public Health Notification: Paralysis from Absorbable Hemostatic Agent [ARCHIVED] 4/2/04
FDA Public Health Web Notification: Counterfeit Polypropylene Mesh [ARCHIVED] 12/19/03
FDA Public Health Notification: Safety Tips for Preventing Hospital Bed Fires [ARCHIVED] 12/18/03
FDA Public Health Notification: Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System [ARCHIVED] 12/17/03
FDA Public Health Web Notification*: Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent [ARCHIVED] 11/25/03
FDA Public Health Web Notification*: Updated Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent (2nd archival) [ARCHIVED] 11/25/03
FDA Public Health Web Notification*: Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent (1st archival) [ARCHIVED] 10/29/03
FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads [ARCHIVED] 12/19/02
FDA Public Health Web Notification*: Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine [ARCHIVED] 10/31/02
FDA Public Health Web Notification: Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription [ARCHIVED] 10/23/02
FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc. [ARCHIVED] 8/21/02
FDA Public Health Web Notification*: Risk of Bacterial Meningitis in Children with Cochlear Implants [ARCHIVED] 7/24/02
FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP [ARCHIVED] 7/12/02
FDA Safety Alert: Recall of Ob/Gyn and Surgical Products [ARCHIVED] 3/15/02
FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients [ARCHIVED] 11/2/01
FDA Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels [ARCHIVED] 7/20/2001
FDA Public Health Notification: Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA) [ARCHIVED] 4/27/2001
FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers [ARCHIVED] 3/13/2001

Archive: 1996-2000

TitleDate
FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia [ARCHIVED] 10/11/2000
Potential for Injury from Circumcision Clamps [ARCHIVED] 8/29/2000
FDA Public Health Advisory: Risk of Electromagnetic Interference with Medical Telemetry Systems [ARCHIVED] 7/10/2000
FDA Urgent Information: Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays [ARCHIVED] 3/29/2000
Important Information Regarding the Year 2000 Transition [ARCHIVED] 12/30/00
FDA Public Health Notification: Important Information about Y2K and Medical Devices [ARCHIVED] 12/13/99
Complications Related to the Use of Vascular Hemostasis Devices [ARCHIVED] 10/8/99
FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System [ARCHIVED] 9/10/99
FDA Safety Alert: Potential Cross-Contamination Linked to Hemodialysis Treatment [ARCHIVED] 5/11/99
Hypotension and Bedside Leukocyte Reduction Filters [ARCHIVED] 5/4/99
Glass Capillary Tubes: Joint Safety Advisory About Potential Risks [ARCHIVED] 2/22/99
FDA And NIOSH Public Health Advisory: Explosions and Fires in Aluminum Oxygen Regulators [ARCHIVED] 2/4/99
FDA Medical Device Malfunction Advisory [ARCHIVED] 12/29/98
Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment [ARCHIVED] 10/14/98
NIR ON™ Ranger™ w/SOX™ PREMOUNTED STENT SYSTEM [ARCHIVED] 10/8/98
Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators [ARCHIVED] 9/28/98
FDA Public Health Advisory: Need for CAUTION When Using Vacuum Assisted Delivery Devices [ARCHIVED] 5/21/98
FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System [ARCHIVED] 4/13/98
FDA Public Health Advisory: Interference Between Digital TV Transmissions and Medical Telemetry Systems [ARCHIVED] 3/20/98
FDA Public Health Notice: Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices [ARCHIVED] 3/13/98
FDA Safety Alert: Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera [ARCHIVED] 3/12/98
FDA Public Health Notice: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera [ARCHIVED] 2/13/98
Notice about Vacuum Loss in Electronic Resonating Components [ARCHIVED] 8/13/97
FDA Public Health Advisory: Limitations of Toxoplasma IgM Commercial Test Kits [ARCHIVED] 7/25/97
FDA Public Health Advisory: Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease [ARCHIVED] 7/7/97
Update to FDA Public Health Notice Radioactivity in Radiation Protection Devices [ARCHIVED] 6/13/97
Radioactivity in Radiation Protection Devices [ARCHIVED] 6/13/97
Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses [ARCHIVED] 5/21/97
Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities [ARCHIVED] 4/17/97
FDA Safety Alert: Risks of Devices for Direct Detection of Group B Streptococcal Antigen [ARCHIVED] 3/24/97
Important Information Relating to Cellulose Acetate Dialyzers [ARCHIVED] 12/19/96
FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves [ARCHIVED] 6/27/96

Archive: 1991-1995

TitleDate
FDA/CPSC Public Health Advisory - Hazards Associated With The Use of Electric Heating Pads [ARCHIVED] 12/12/95
Public Health Advisory: Retinal Photic Injuries From Operating Microscopes During Cataract Surgery [ARCHIVED] 10/16/95
Urgent Notice About Recalled Blood Glucose Test Strips [ARCHIVED] 10/11/95
FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails [ARCHIVED] 8/23/95
Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures [ARCHIVED] 9/30/94
Important Information About TMJ Implants [ARCHIVED] 7/15/94
Hazards of Precipitation Associated With Parenteral Nutrition [ARCHIVED] 4/18/94
Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices [ARCHIVED] 3/1/94
Occluded Endotracheal Tubes [ARCHIVED] 2/28/94
Safety Alert: Laerdal Defibrillators [ARCHIVED] 1/26/94
Public Health Advisory: Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices [ARCHIVED] 12/28/93
Hazards of Volume Ventilators and Heated Humidifiers [ARCHIVED] 9/15/93
Safety Alert: Unsafe Patient Lead Wires and Cables [ARCHIVED] 9/3/93
Fluoride Contamination of Hemodialysis Water Supply [ARCHIVED] 8/19/93
Hazards of Heated-Wire Breathing Circuits [ARCHIVED] 7/14/93
MRI-Related Death of Patient With Aneurysm Clip [ARCHIVED] 11/25/92
Important Information About Studies on Dialyzer Germicides [ARCHIVED] 10/23/92
Potential Hazards With Restraint Devices [ARCHIVED] 7/15/92
FDA Safety Alert: Caude Equina Syndrome - Use of Catheters. [ARCHIVED] 5/29/92
Aluminum and Other Trace-Element Contamination in Dialysis Facilities [ARCHIVED] 5/20/92
Information on Shiley CC Valve Fractures [ARCHIVED] 4/21/92
Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V. [ARCHIVED] 4/16/92
Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes [ARCHIVED] 3/6/92
Vitek Proplast Temporomandibular Joint Implants [ARCHIVED] 9/1991

Archive: 1983-1990

TitleDate
Serious Problems With Proplast-Coated TMJ Implant [ARCHIVED] 12/28/90
Hepatitis B Transmission Via Spring-Loaded Lancet Devices [ARCHIVED] 8/28/90
Gas/Air Embolism Associated With Intrauterine Laser Surgery [ARCHIVED] 5/11/90
Important Tips for Apnea Monitor Users [ARCHIVED] 2/16/90
New FDA Recommendations and Results of Contact Lens Study [ARCHIVED] 5/30/89
Sodium Azide Contamination of Hemodialysis Water Supplies [ARCHIVED] 3/15/89
Homemade Saline Solutions for Lenses [ARCHIVED] 1/24/89
Chloramine Contamination of Hemodialysis Water Supplies [ARCHIVED] 2/19/88
FDA Safety Alert - Possibly Contaminated Dura Mater [ARCHIVED] 4/28/87
Danger Involving Apnea Monitors [ARCHIVED] 6/19/85
FDA Alert - Pediatric Cribs [ARCHIVED] 7/2/84
Dialyzer: First-Use Syndrome [ARCHIVED] 11/20/83
FDA Safety Alert - Breathing System Connectors [ARCHIVED] 9/2/83
FDA Safety Alert - Electrically Powered Hospital Beds [ARCHIVED] 6/16/83

Page Last Updated: 09/17/2015
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