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.
- 2017-07-12FDA-DeviceExactech, Inc.Class IIEXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
- 2017-07-12FDA-DeviceExactech, Inc.Class IIEXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
- 2017-07-12FDA-DeviceExactech, Inc.Class IIEXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
- 2017-07-12FDA-DeviceExactech, Inc.Class IILogic Fit Tibial Tamp Head
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
- 2017-07-12FDA-DeviceMedacta Usa IncClass IIMedacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
One lot of product does not include a screw for attachment to the tibial base plate.
- 2017-07-12FDA-DeviceLeica Microsystems, Inc.Class IINussloch GmbH ASP6025 Tissue Processor
Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.
- 2017-07-12FDA-DeviceEncore Medical, LpClass II3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
- 2017-07-12FDA-DeviceEncore Medical, LpClass II3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
- 2017-07-12FDA-DeviceCardioTek BVClass IICardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Software bug which allows parameters to be changed unintentionally during use.
- 2017-07-12FDA-DeviceJAS Diagnostics Inc.Class IIDrew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
May result in elevated platelet backgrounds during routine startup/background checks.
- 2017-07-12FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
- 2017-07-05FDA-DeviceShimadzu Medical Systems Usa ComClass IISHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
- 2017-07-05FDA-DeviceShimadzu Medical Systems Usa ComClass IISHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
- 2017-07-05FDA-DeviceShimadzu Medical Systems Usa ComClass IISHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
- 2017-07-05FDA-DeviceAGFA Healthcare Corp.Class IIIMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
- 2017-07-05FDA-DeviceCarestream Health IncClass IIDRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
- 2017-07-05FDA-DeviceMedtest Holdings, Inc.Class IIIPointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Linear performance information in product insert does not match that listed in the approved premarket notification
- 2017-07-05FDA-DeviceMedtest Holdings, Inc.Class IIIThe Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Incorrect control range in product labeling
- 2017-07-05FDA-DeviceOnkos Surgical, Inc.Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- 2017-07-05FDA-DeviceOnkos Surgical, Inc.Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- 2017-07-05FDA-DeviceOnkos Surgical, Inc.Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- 2017-07-05FDA-DeviceExactech, Inc.Class IIExactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
- 2017-07-05FDA-DeviceMerge Healthcare, Inc.Class IIMasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- 2017-07-05FDA-DeviceMerge Healthcare, Inc.Class IIMasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- 2017-07-05FDA-DeviceMerge Healthcare, Inc.Class IIMasimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- 2017-07-05FDA-DeviceMerge Healthcare, Inc.Class IISpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- 2017-07-05FDA-DeviceDeRoyal Industries IncClass IIDeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
- 2017-07-05FDA-DeviceBeckman Coulter Inc.Class IIAccess System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
The Access immunoassays are susceptible to biotin interference.
- 2017-07-05FDA-DeviceBeckman Coulter Inc.Class IIAccess System-Free T4 Assay, B01902E, Catalog No. 33880
The Access immunoassays are susceptible to biotin interference.
- 2017-07-05FDA-DeviceBeckman Coulter Inc.Class IIAccess Thyroglobulin, A34085G, Catalog No. 33860
The Access immunoassays are susceptible to biotin interference.
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