Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceSteris CorporationClass IIMedisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceBioventus, LLCClass IIEXOGEN Ultrasound Coupling Gel
Product may contain white particulates that are microbial in nature.
- 2021-01-20FDA-DeviceCook Medical LlcClass IIDisposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
- 2021-01-20FDA-DeviceClerio VisionClass IIClerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
- 2021-01-20FDA-DeviceBaxter Healthcare CorporationClass IIVERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
- 2021-01-20FDA-DeviceSiemens Medical Solutions USA, IncClass IIUroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
- 2021-01-20FDA-DeviceSiemens Medical Solutions USA, IncClass IIUroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
- 2021-01-20FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
- 2021-01-20FDA-DeviceRemel IncClass IIRemel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
- 2021-01-20FDA-DeviceBoston Scientific CorporationClass ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
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