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.
- 2017-04-26FDA-DevicePhilips Electronics North America CorporationClass IIUNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
- 2017-04-26FDA-DevicePhilips Electronics North America CorporationClass IIAllura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 722038; Allura Xper FD20/20 biplane OR Table 722039
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
- 2017-04-19FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blun
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
- 2017-04-19FDA-DeviceKeystone Dental IncClass IIKeystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
- 2017-04-19FDA-DeviceMicromedics, Inc.Class IINordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
- 2017-04-19FDA-DeviceHill-Rom, Inc.Class IITotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
- 2017-04-19FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRadiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
- 2017-04-19FDA-DeviceAesculap Implant Systems LLCClass IIAESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-Device2k Innovations Inc.Class IIVolt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
- 2017-04-19FDA-DeviceBioMerieux SAClass IIVIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIVitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIVitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IISetup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIPRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIPlastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIOrtho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIOphthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IIMinor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- 2017-04-19FDA-DeviceWindstone Medical Packaging, Inc.Class IILasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
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