All Recalls | RecallPedia

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

EXOGEN Ultrasound Coupling Gel

Bioventus

🏥 Medical Devices Class I - Dangerous

Product may contain white particulates that are microbial in nature.

Dec 17, 2020 Other Medical Devices Nationwide View Details →

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

ICU Medical

🏥 Medical Devices Class I - Dangerous

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Nov 9, 2020 Diagnostic Equipment Nationwide View Details →

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

Ortho Clinical Diagnostics

🏥 Medical Devices Class I - Dangerous

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

Dec 15, 2020 Infusion Pumps Nationwide View Details →

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

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.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

VISBY MEDICAL

🏥 Medical Devices Class I - Dangerous

Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.

Dec 5, 2020 Diagnostic Equipment Nationwide View Details →

Naturalyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

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.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate drums, Product Code 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

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.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Citrasate 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

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.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Clerio 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.

Clerio Vision

🏥 Medical Devices Class I - Dangerous

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

Dec 10, 2020 Other Medical Devices Nationwide View Details →

Citrasate 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

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.

Nov 17, 2020 Surgical Instruments Nationwide View Details →

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte 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.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Rapala® Rechargeable Fillet Knives (Item No. RRFN)

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The battery can overheat and catch fire if non-Rapala chargers are used to charge the battery.

Jan 19, 2021 Other Consumer Products Nationwide View Details →

Scalpa Numb Maximum Strength Topical Anesthetic Cream

Scalpa Inc., of Phoenix, Ariz.

🏠 Consumer Products Class II - Moderate

The product contains the substance lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning to young children.

Jan 14, 2021 Other Consumer Products Nationwide View Details →