878 results
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14ms
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Sources: EU EUDAMED, US FDA
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
FDA Recall
Open, Classified
·Agilent Technologies·Product code KPA·April 2, 2024
Apo B Reagent, REF: OSR6143
FDA Recall
Open, Classified
·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code JHN·April 23, 2025
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FPO·May 12, 2021
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·May 31, 2022
Diasol Acid Concentrate REF G100325-10Dex 100
FDA Recall
Open, Classified
·Diasol, Inc·Product code KPO·July 27, 2022
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Recall
Open, Classified
·Diasol, Inc·Product code KPO·November 5, 2025
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
FDA Recall
Open, Classified
·Nipro Renal Soultions USA, Corporation·Product code KPO·April 11, 2025
Citrasate 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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FPO·May 12, 2021
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Recall
Open, Classified
·Diasol, Inc·Product code KPO·November 5, 2025
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Recall
Open, Classified
·Diasol, Inc·Product code KPO·November 5, 2025
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
FDA Recall
Open, Classified
·NxStage Medical Inc·Product code KPO·April 28, 2025
Naturalyte Liquid Acid concentrate bottles, Product Code 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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020
NaturaLyte 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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
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.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 23, 2020