Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-05-03FDA-DeviceOrthosoft, Inc. dba Zimmer CASClass IINavitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
- 2017-05-03FDA-DeviceSavaria Concord Lifts, Inc.Class IIOmega Incline Platform Lift
Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail
- 2017-05-03FDA-DeviceArrow International IncClass IIPressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBS
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
- 2017-05-03FDA-DeviceUlrich Medical USA IncClass IIuNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
- 2017-05-03FDA-DeviceCardiovascular Systems IncClass IIViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic mate
CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
- 2017-05-03FDA-DeviceBecton Dickinson & Co.Class IIIBBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
- 2017-05-03FDA-DeviceSiemens Medical Solutions USA, Inc.Class II18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Muscul
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
- 2017-05-03FDA-DeviceHeartwareClass IHeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
- 2017-05-03FDA-DeviceHeartwareClass IHeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
- 2017-04-26FDA-DeviceLaerdal Medical CorporationClass IILaerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800
The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
- 2017-04-26FDA-DeviceCP Medical IncClass IIPGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
- 2017-04-26FDA-DeviceC.R. Bard, Inc.Class IISURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
- 2017-04-26FDA-DeviceCook Inc.Class IIBush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Product may overheat, melt, and burn patient.
- 2017-04-26FDA-DeviceElcam Medical, Inc.Class IIElcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
The stopcock was found to have punctures.
- 2017-04-26FDA-DeviceOrthosoft, Inc. dba Zimmer CASClass IISmartTools Knee System Orthopedic Stereotaxic Instrument
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
- 2017-04-26FDA-DeviceMizuho OSIClass II216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
- 2017-04-26FDA-DeviceBd DiagnosticClass IIBD Viper LT software, version 3.00H
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
- 2017-04-26FDA-DeviceAvid Medical, Inc.Class IIVacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained and corrected. A full inventory analysis was conducted reviewing all vacutainer component inventories. The issue was found to affect a total of five vacutainer components.
- 2017-04-26FDA-DeviceBD LIFE SCIENCESClass IISoftware version 4.44A utilized on the BD MAX System
The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants Custom parts Product Usage: Custom
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceZimmer Biomet, Inc.Class IIvarious polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IID-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IID-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IID-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IIPeri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- 2017-04-26FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IINAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief