1,525 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code LPN·June 23, 2022
B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYB·May 8, 2006
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
FDA Recall
Open, Classified
·Kamiya Biomedical Company, LLC·Product code CFF·September 28, 2022
Clinical Chemistry Phosphorus assay
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CEO·May 4, 2010
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CEO·January 30, 2007
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
FDA Recall
Terminated
·Alfa Wassermann, Inc.·Product code CEO·October 10, 2012
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
Clinical Chemistry Uric Acid; LN 7D76-20
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code CDO·March 18, 2004
V8 Immunodisplacement Kit REF 1803
FDA Recall
Open, Classified
·Helena Laboratories, Corp.·Product code CFF·April 6, 2022
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code CEO·April 24, 2025
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEO·February 22, 2013
IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFF·January 28, 2004
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Recall
Terminated
·Helena Laboratories, Corp.·Product code CFF·July 21, 2017
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CEO·June 12, 2013
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CEO·August 12, 2013
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
FDA Recall
Terminated
·Alivecor SFO·Product code DXH·January 9, 2015
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012