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.
- 2018-03-28FDA-DeviceBoston Scientific CorporationClass IIRe-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urotheli
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- 2018-03-28FDA-DeviceBoston Scientific CorporationClass IIRe-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urotheli
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- 2018-03-28FDA-DeviceBoston Scientific CorporationClass IIMalecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- 2018-03-28FDA-DeviceBoston Scientific CorporationClass IIMalecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- 2018-03-28FDA-DeviceBoston Scientific CorporationClass IIMalecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIWOUND CLOSURE TRAY - FACIAL
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIWOUND CARE KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIEXCISION TRAY
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IINEONATAL IV START KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIINFANT IV SECUREMENT KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIIV START KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIPEDIATRIC IV & IV START KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IILATEX FREE IV START SET
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IINEONATAL IV ACCESS SET
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIBLOOD DRAW KIT
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIINCISION & DRAINAGE TRAY or KIT
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIMINOR DRESSING CHANGE TRAY
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IITUBING CHANGE KIT
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IISorbaView Shield Dressing Change Tray
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIST. CHRISTOPHER'S SECUREMENT SET
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IICATHETER SECUREMENT SYSTEM
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IICIRCUMCISION TRAY
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIMINI PLASTICS SET
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIGENERAL PURPOSE INSTRUMENT TRAY
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IISUTURE REMOVAL TRAY, SET or KIT
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IISKIN STAPLE REMOVER
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- 2018-03-28FDA-DeviceEpigenomics AgClass IIEpi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
The diagnostic test kit may produce invalid test runs which may delay test results.
- 2018-03-28FDA-DeviceGenicon, Inc.Class IIGENICON EZEE Retrieval, sterile, Rx only.
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
- 2018-03-28FDA-DeviceIridex CorporationClass IIIridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
- 2018-03-28FDA-DeviceMonteris Medical CorpClass IMONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
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