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.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIXMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIIMRI MOTOR Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIIMRI AIR CONTROL Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIBLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II19cm Attachment, Black Max Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAutolube-III with NK Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAutolube-III with Irrigation Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAutolube-III with Foot Guard Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAL-III-DISS Adapter Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAutolube-III with 20ft hose Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAutolube-III Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIFoot control irrigation system Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIAL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II14cm QD Angle Attachment Product Usage: Product attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
- 2017-05-10FDA-DeviceDale Medical Products, Inc.Class IIDale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
- 2017-05-10FDA-DeviceDale Medical Products, Inc.Class IIDale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
- 2017-05-10FDA-DeviceNatus Medical IncorporatedClass IISecond generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
- 2017-05-10FDA-DeviceMerge Healthcare, Inc.Class IISchiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.
- 2017-05-10FDA-DeviceBoston Scientific CorporationClass IIThe JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.
- 2017-05-10FDA-DeviceRoho Inc.Class IIROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
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