    |
| FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
Medical Device Recalls |
 |
A recall is a correction or removal of a product that:
a) is defective
b) could be a risk to health, or
c) is in violation of FDA regulations.
Recalls may be conducted on a firm's own initiative or by FDA request. If the company does not comply with FDA's recall request, the FDA can seek a court order to seize the product, require the manufacturer to cease distribution and/or require the manufacturer to notify all persons who use the product.
Most recalls are carried out voluntarily by the manufacturer or distributor of the product. However, FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the firm does not recall the product on their own. The cooperation between FDA and its regulated industries has proven to be the quickest and most reliable method to remove potentially dangerous products from the market.
The risk to public health associated with a recall is represented by three categories: Class I, II, and III. FDA classifies recalls into one of these categories. Class I represents the highest level of risk and is reserved for products that could likely cause serious health problems or death.
This site provides information on Class 1 medical device recalls, and some Class II and III recalls with general public interest.
If you need further information on medical device recalls, or other FDA product areas, please refer to the Weekly Enforcement Report at: http://www.fda.gov/opacom/Enforce.html or FDA's Recalls and Safety Alerts at: http://www.fda.gov/opacom/7alerts.html
| Device Name | Date Initiated | Links |
|---|---|---|
| Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills | 10/27/04 |  |
| Advanced Bionics Cochlear Auditory Implants | 9/24/04 | |
| Pulmonetic Systems LTV Series of Ventilators | 9/8/04 | |
| Medtronic 8870 Software Application Card Version AAA 02 | 8/24/04 | |
| Nellcor CapnoProbe Sublingual Sensor | 8/24/04 | |
| Medibo Minerva Patient Lifts | 8/4/04 | |
| Boston Scientific Express2TM (bare metal) Coronary Stent | 7/16/04 | |
| Shiley Tracheosoft Tracheostomy Tube and Disposable Inner Cannula | 7/8/04 | |
| Boston Scientific Taxus™ Express2TM (paclitaxel-eluting) Coronary Stent | 7/1/04 | |
| Arjo Alenti Lift Hygiene Chair | 6/8/04 | |
| Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack | 6/7/04 | |
| Carl Zeiss Meditec Ophthalmic System | 6/3/04 | |
| Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers | 5/24/04 | |
| Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation | 5/5/04 | |
| Roche Diagnostics Tecan Clinical Workstation | 5/5/04 | |
| PRECISE® RX Nitinol Stent Transhepatic Biliary System | 5/4/04 | |
| Tecan Clinical Workstation with RoboNet Software | 5/3/04 | |
| Arjo MINSTREL Patient Lifts | 4/30/04 | |
| VITEK GPS-107 Cards (Additional Lot) | 4/20/04 | |
| Micro Jewel II and GEM DR ICDs (implantable cardioverter-defibrillators) | 4/4/04 | |
| Roche Diagnostics Tecan Clinical Workstation | 3/5/04 | |
| MiniMed Paradigm Quick-set Plus Insulin Administration Set | 3/2/04 | |
| VITEK GPS-107 Cards | 1/28/04 | |
| Faaborg Patient Lifts | 1/21/04 | |
| ComfortGel Nasal Masks | 9/29/03 | |
| CoaguChek PT Test Strips | 9/12/03 | |
| Laboratory Information System Software Device, version 5.3 | 8/12/03 | |
| VIDAS Chlamydia Assay | 8/6/03 | |
| ProbeTec ™ ET Instrument | 7/21/03 | |
| Portex Resuscitator | 11/15/02 | |
| Tri-State Hospital Supply Corp. Recalls Oral Swabs Due to Potential Choking Hazard | 11/6/02 | |
| Baxter Intravenous Filter Sets | 10/17/02 | |
| Gonorrhea Test Kits Recalled by Abbott Laboratories | 8/30/02 | |
| Roche Diagnostics Accu Chek Blood Glucose Monitoring System | 8/2/02 | |
| CAPTIA Syphilis G Elisa Test Kit Lot Numbers K00841, K00842, K00838 and K00839 |
7/22/02 | |
| Disetronic D-TRON Insulin Infusion Pump | 6/17/02 | |
| Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 | 6/3/02 | |
| Bassinets with drop leaf work surface, models 248 and
1251 |
3/20/02 | |
| Olympus America Issues Voluntary Recall of Suspect Video
Bronchoscopes |
3/20/02 | |
| FDA Issues Nationwide / International Alert on Recalled OB/GYN and Surgical Devices Due to Health Risk | 3/14/02 | |
| Pulmonetic Systems LTV Series Ventilator, Models LTV 1000, LTV 950, LTV 900 and LTV 800 | 3/12/02 | |
| Bard RapidFire Multiple Band Ligator (Item No. 000608) |
1/31/02 | |
| FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths | 11/07/01 | |
| Recall of Zirconia Ceramic Femoral Heads for Hip Implants | 08/14/01 | |
| Solar 9500 Physiological ECG Monitor | 07/20/01 | |
| ESPRIT Ventilator | 6/8/2001 | |
| Adcon-L and Adcon-T/N sterile | 01/19/2001 | |
| Puritan-Bennett Ventilator, Model 840 | 12/22/2000 | |
| Gelfoam Sterile Powder and Sponge |
11/17/2000 | |
Updated October 27, 2004
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH