Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-09-19FDA-DeviceOrtho-Clinical DiagnosticsClass IIIVITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage:
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
- 2018-09-19FDA-DeviceOrtho-Clinical DiagnosticsClass IIIVITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
- 2018-09-19FDA-DeviceLeMaitre Vascular, Inc.Class IIAnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIVascular Solutions Venture Rx Catheter, 6F, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceSPS Sterilization, IncClass IIEdwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 2018-09-19FDA-DeviceVascular Technology, Inc.Class IIVTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
- 2018-09-19FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrume
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
- 2018-09-19FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrume
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
- 2018-09-19FDA-DeviceNordicNeuroLab ASClass IIfMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
- 2018-09-19FDA-DeviceMicro Therapeutics Inc, Dba Ev3 NeurovascularClass IIev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
- 2018-09-19FDA-DeviceCardiovascular Systems IncClass IICSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbi
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
- 2018-09-19FDA-DeviceStryker NeurovascularClass IIWingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
- 2018-09-19FDA-DeviceRemel IncClass IIremel THIOGLYCOLLATE MEDIUM, REF 05152
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
- 2018-09-19FDA-DeviceRemel IncClass IIremel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
- 2018-09-19FDA-DeviceRemel IncClass IIremel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
- 2018-09-19FDA-DeviceOhio Medical CorporationClass IIPortable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
- 2018-09-19FDA-DeviceDiagnostica Stago, Inc.Class IIDiagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
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