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Medical Devices

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Archived Safety Alerts, Public Health Advisories and Notices

The following documents have been designated “Archived” because some or all of the information in them is no longer current. They are provided for historical reference.

 

Date of Issue Title
12/11/2007
(See 9/24/08 Update)		 Deaths reported following Radio Frequency Ablation of Lung Tumors
2/27/2007
(See 7/16/07 Update)		 Custom Ultrasonics, Inc. Endoscope Washer/Disinfectors
4/18/2007
(See 4/19/07 Update)

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
4/28/2006 Important Safety Recommendations for Baxter's COLLEAGUE Infusion Pumps
12/20/2005
(See 2/1/07 Update)		 Update of Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device
4/24/2006
(See 6/19/06 Update)		 Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals
4/21/2006
(See 5/31/06 Update)		 Fungal Keratitis Infections Related to Contact Lens Use (First Update)
4/10/2006
(See 5/31/06 Update)		 Fungal Keratitis Infections Related to Contact Lens Use
10/27/2005 New Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device
10/14/2005

Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD)

See Related Document: Advice to Patients
8/23/2005
(See 2/27/06 Update)		 Gambro Prisma® Continuous Renal Replacement System
7/24/2002
Updated:
9/25/2003		 Risk of Bacterial Meningitis in Children with Cochlear Implants
11/25/2003 Updated Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent
10/29/2003 Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent
8/21/2002 Human Tissue Processed by Cryolife, Inc
3/15/2002 Recall of Ob/Gyn and Surgical Products Manufactured by A & A Medical/Rocket USA/Lifequest
3/29/2000 Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays
12/30/1999 Important Information Regarding the Year 2000 Transition
12/13/1999 FDA Public Health Notification: Important Information about Y2K and Medical Devices
12/29/1998 FDA Medical Device Malfunction
10/14/1998 Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment
8/5/1997 Update to Radioactivity in Radiation Protection Devices
6/13/1997 Radioactivity in Radiation Protection Devices
10/11/1995 Urgent Notice About Recalled Blood-Glucose Test Strips
1/26/1994 Laerdal Defibrillators
8/20/1992 Important Information About Rophae Intraocular Lenses
7/2/1984 Pediatric Cribs
    
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