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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

Lusys Laboratories

Class I - Dangerous

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details →

da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

Teleflex Medical

Class I - Dangerous

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

Mar 13, 2015 Other Medical Devices Nationwide View Details →

Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

Bacterin International

Class I - Dangerous

Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted.

Mar 9, 2015 Implants & Prosthetics View Details →

da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Diagnostic Equipment View Details →

da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Diagnostic Equipment View Details →

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

TEM Systems

Class I - Dangerous

Some of vials were found to be partially filled.

Oct 23, 2014 Other Medical Devices Nationwide View Details →

VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

VasoNova

Class I - Dangerous

A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

Mar 30, 2015 Surgical Instruments Nationwide View Details →

CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals

CooperSurgical

Class I - Dangerous

Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

May 1, 2013 Surgical Instruments Nationwide View Details →

da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Diagnostic Equipment View Details →

CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

Carestream Health

Class I - Dangerous

Units device head descended unexpectedly

Jan 8, 2015 Diagnostic Equipment Nationwide View Details →

da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patient.

Carestream Health

Class I - Dangerous

Units device head descended unexpectedly

Jan 8, 2015 Diagnostic Equipment Nationwide View Details →

da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.

Siemens Healthcare Diagnostics

Class I - Dangerous

Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the LIS. Manual intervention is necessary to complete the processing of the samples that are held Inprocess.

Feb 11, 2015 Diagnostic Equipment View Details →

da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Intuitive Surgical

Class I - Dangerous

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Mar 16, 2015 Surgical Instruments View Details →

Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

Biomerieux

Class I - Dangerous

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Feb 25, 2015 Diagnostic Equipment View Details →