Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-09-11FDA-DeviceHaag-Streit USA IncClass IIHS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating
software error in the central control unit of the floor stand.
- 2019-09-11FDA-DeviceOMNIlife science Inc.Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 2019-09-11FDA-DeviceOMNIlife science Inc.Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 2019-09-11FDA-DeviceOMNIlife science Inc.Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 2019-09-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas c513 Analyzer
Quality issue with high pressure solenoid valves
- 2019-09-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IICobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Quality issue with high pressure solenoid valves
- 2019-09-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Quality issue with high pressure solenoid valves may cause inaccurate results.
- 2019-09-11FDA-DeviceAlere San Diego, Inc.Class IIAlere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio a
The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IICE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IIFEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IIES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceB. Braun Medical, Inc.Class IIES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
The filter capacity is not achieved due to damage of the filter membrane.
- 2019-09-11FDA-DeviceSonarMed IncClass IISonarMed AirWave Monitor, Model Number M0001
Potential for the presence of two error codes which would make the monitor inoperable.
- 2019-09-11FDA-DeviceLeMaitre Vascular, Inc.Class IIThe LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
incorrect device size being listed on the impacted device packaging
- 2019-09-11FDA-DeviceKarl Storz EndoscopyClass IIFlexible Intubation Fiberscope, Model # 11301AB1
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
- 2019-09-11FDA-DeviceStryker CommunicationsClass IIBerchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
The mounts on the monitor may have an insufficient weld.
- 2019-09-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IIThe Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.
- 2019-09-11FDA-DeviceAngiodynamics, Inc.Class IIAngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
- 2019-09-11FDA-DeviceCareFusion 303, Inc.Class IIAlaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
- 2019-09-11FDA-DeviceBoston Scientific CorporationClass IIAMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
- 2019-09-11FDA-DeviceFujifilm Medical Systems U.S.A., Inc.Class IIFujifilm FDR Go Plus mobile X-ray system
The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- 2019-09-11FDA-DeviceSiemens Medical Solutions USA, IncClass IIsyngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
- 2019-09-11FDA-DeviceBecton Dickinson & Co.Class IIBD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
- 2019-09-11FDA-DeviceBecton Dickinson & Co.Class IIBD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
- 2019-09-11FDA-DeviceHeidelberg Engineering GmbHClass IISPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Error in the default configuration which could lead to the incorrect display of patient master data.
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