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.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo 924 Safety Screw Spike Set, Product Code 775759
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceCardinal Health Inc.Class IIKangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
The feeding spike sets may leak at the interface of the tube and spike connector.
- 2020-06-03FDA-DeviceHeartware, Inc.Class IHeartware HVAD Pump Implant accessories, Product (REF) Number 1153
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- 2020-06-03FDA-DeviceHeartware, Inc.Class IHeartware HVAD Pump Outflow Graft, Product (REF) Number 1125
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- 2020-06-03FDA-DeviceHeartware, Inc.Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- 2020-06-03FDA-DeviceHeartware, Inc.Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1104
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- 2020-06-03FDA-DeviceHeartware, Inc.Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1103
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- 2020-06-03FDA-DeviceMedtronic Vascular Galway DBA Medtronic IrelandClass IMedtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- 2020-06-03FDA-DeviceNikon MetrologyClass IINikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR 1020.40(c)(1)] due to an insufficient safety margin for the means of attachment of a piece of interior x-ray shielding. Double sided industrial tape was used for attachment - there have been only 2 instances of detachment and although the piece of shielding detached it remained mostly in place supported by wires that pass through that piece of shielding. The repair is accomplished by adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system. Mfr reports that no systems were found to have exceeded the emission limit when checked prior to repair.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceHowmedica Osteonics Corp.Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- 2020-05-27FDA-DeviceNelson Innovaions, LlcClass IINelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
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