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.
- 2018-03-21FDA-DeviceAlden OpticalClass IIAlden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Contact lenses lack sterility assurance.
- 2018-03-21FDA-DeviceAlden OpticalClass IIAlden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Contact lenses lack sterility assurance.
- 2018-03-21FDA-DeviceAlden OpticalClass IINovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
Contact lenses lack sterility assurance.
- 2018-03-21FDA-DeviceAlden OpticalClass IINovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Contact lenses lack sterility assurance.
- 2018-03-21FDA-DeviceZimmer Biomet, Inc.Class IIHumeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
- 2018-03-21FDA-DeviceZimmer Biomet, Inc.Class IIHumeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
- 2018-03-21FDA-DevicePhilips Electronics North America CorporationClass IIIHeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AE
Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
- 2018-03-21FDA-DeviceZOLL Medical CorporationClass IIOneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.
A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.
- 2018-03-21FDA-DeviceDeerfield Imaging, Inc.Class IIIMRIS T2X Table, Part Number 109682-600
The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
- 2018-03-21FDA-DeviceDeerfield Imaging, Inc.Class IIIMRIS ORT100 Table, Part Number 110470-000
The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
- 2018-03-21FDA-DeviceStryker CorporationClass IICMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an
The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
- 2018-03-21FDA-DeviceLaerdal Medical CorporationClass IILCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
- 2018-03-21FDA-DeviceMedimop Medical Projects Ltd.Class IIVial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.
Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.
- 2018-03-21FDA-DeviceBaxter Healthcare CorporationClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
- 2018-03-21FDA-DeviceRandox LaboratoriesClass IIIImmunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- 2018-03-21FDA-DeviceRandox LaboratoriesClass IIIImmunoassay Premium Controls (3x4x5mL and 12x5mL packages)
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- 2018-03-21FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
- 2018-03-21FDA-DeviceORTHO SOLUTIONS, LTD.Class IISYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.
Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
- 2018-03-21FDA-DeviceCook Inc.Class IIFemoral Artery Pressure Monitoring Set
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IILeft Atrial Catheter Set
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IICentral Venous Catheter Tray
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IITFE Coated Curved Newton LLT
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIRosen Curved Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIReuter Tip Deflecting Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IINewton Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIMovable Core Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIFixed Core Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIFixed Core Bentson
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIDouble Flexible Tipped Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIDisposable Reuter Tip Deflecting Wire Guide
Label does not state that the product is heparin-coated.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief