45 results
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22ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Recall
Terminated
·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·May 22, 2012
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·May 22, 2012
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·May 22, 2012
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
FDA Recall
Open, Classified
·Raz Design Inc·Product code INN·January 5, 2026
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
FDA Recall
Terminated
·Cordis Corporation·Product code DQY·December 7, 2004
Pereyra-Raz Ligature Carrier
FDA Recall
Terminated
·Cook Inc.·Product code GEJ·April 25, 2017
CYTO-STAT tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·September 16, 2010
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·September 16, 2010
Raindrop Near Vision Inlay, Model# RD1-1
FDA Recall
Terminated
·Revision Optics Inc·Product code LQE·February 7, 2017
Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·August 26, 2003
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
FDA Recall
Terminated
·RVO 2.0, INC·Product code LQE·November 13, 2018
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
FDA Recall
Terminated
·LivaNova USA Inc.·Product code DTL·April 24, 2020
Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008
Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·January 12, 2018
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·January 12, 2018
Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Material Number (OUTER CARTON LABEL OF 5pk) /Material Number (INNER-POUCH LAB LE FOR EACH SINGLE CATHETER)/ Catalog Number /Material Description: M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5; M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5; M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5; M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5; M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5; M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5; M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5; M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5; M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5; M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5; M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5; M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5; M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5; M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5; M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5; M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5; M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5; M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5; M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5; M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5; M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5; M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5; M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5: M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5; M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5; M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5; M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5; M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5; M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5; M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5; M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5; M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5; M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5; M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035; M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035; M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035; M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035; M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035; M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035; M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035; M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 and M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035. Imager " II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQO·October 22, 2009
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code JJE·October 19, 2023