Class I - Dangerous
Product coatings require 510K approval.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Product coatings require 510K approval.
Class I - Dangerous
Product coatings require 510K approval.
Class I - Dangerous
Product coatings require 510K approval.
Class I - Dangerous
Product coatings require 510K approval.
MyRay RXDC dental unit x-ray unit
CEFLA DENTAL GROUP
Class I - Dangerous
The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Roche Molecular Systems
Class I - Dangerous
In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
Class I - Dangerous
Product coatings require 510K approval.
Molift Smart 150
Moller Vital
Class I - Dangerous
The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
Class I - Dangerous
Product coatings require 510K approval.
Class I - Dangerous
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
Class I - Dangerous
Product coatings require 510K approval.
Class I - Dangerous
Product coatings require 510K approval.
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Coloplast Manufacturing US
Class I - Dangerous
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
Separation Technology
Class I - Dangerous
Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
Class I - Dangerous
The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
Molift Smart 150
Moller Vital
Class I - Dangerous
The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
Class I - Dangerous
When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
Class I - Dangerous
Product coatings require 510K approval.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
Becton Dickinson &
Class I - Dangerous
Microbiological media may be contaminated with bacteria.