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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.

Iradimed

Class I - Dangerous

Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.

Aug 24, 2012 Diagnostic Equipment Nationwide View Details →

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Cooper Surgical

Class I - Dangerous

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Oct 31, 2012 Surgical Instruments Nationwide View Details →

220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems

Class I - Dangerous

Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be

Nov 14, 2012 Other Medical Devices Nationwide View Details →

The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

Medtronic Navigation

Class I - Dangerous

Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.

Nov 13, 2012 Surgical Instruments Nationwide View Details →

GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare

Class I - Dangerous

GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

Aug 1, 2012 Diagnostic Equipment Nationwide View Details →

100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems

Class I - Dangerous

Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limi

Nov 14, 2012 Other Medical Devices Nationwide View Details →

GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare

Class I - Dangerous

GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

Aug 1, 2012 Diagnostic Equipment Nationwide View Details →

The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.

Diamedix

Class I - Dangerous

Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

Aug 6, 2012 Diagnostic Equipment Nationwide View Details →

GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare

Class I - Dangerous

GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

Aug 1, 2012 Diagnostic Equipment Nationwide View Details →

NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Zimmer

Class I - Dangerous

Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset

Sep 21, 2012 Implants & Prosthetics View Details →

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Cooper Surgical

Class I - Dangerous

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Oct 31, 2012 Surgical Instruments Nationwide View Details →

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

Biomet

Class I - Dangerous

It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

Nov 6, 2012 Implants & Prosthetics Nationwide View Details →

Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.

Metrex Research

Class I - Dangerous

The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).

Sep 20, 2011 Infusion Pumps Nationwide View Details →

Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.

First Medical Source

Class I - Dangerous

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The pr

Jul 9, 2011 Infusion Pumps Nationwide View Details →

Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .

Microgenics

Class I - Dangerous

In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

Aug 20, 2012 Implants & Prosthetics Nationwide View Details →

Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

Superstat

Class I - Dangerous

The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

Oct 24, 2012 Other Medical Devices Nationwide View Details →

Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

Superstat

Class I - Dangerous

The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

Oct 24, 2012 Other Medical Devices Nationwide View Details →