38 results
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24ms
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Sources: EU EUDAMED, US FDA
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TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
FDA Recall
Open, Classified
·MICROVENTION INC.·Product code NOY·December 21, 2023
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code GWM·November 1, 2024
Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.
FDA Recall
Terminated
·Rayes Inc·Product code FNL·November 14, 2005
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.
FDA Recall
Terminated
·Remel Europe Ltd. Clipper Boulevard West Dartford United Kingdom·Product code GOY·July 23, 2020
Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.
FDA Recall
Terminated
·Phillips Safety Products·Product code HOY·June 5, 2008
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42" X 57" SMS (I) TUBE SUCTION CONNECT Y." X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF ( I ) PVP PAINT 8" STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2" ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( I ) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJF·May 20, 2014
AcoSound. Model Number: LW12-BTE-M
FDA Recall
Open, Classified
·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.·Product code QUG·April 25, 2025
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
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
FDA Recall
Terminated
·Philips and Neusoft Medical Systems Co., Ltd. No. 2 Xiu xiu Street Hunnan; Sujiatun Shenyang China·Product code JAK·March 24, 2016
The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.
FDA Recall
Terminated
·Tung Keng Enterprise Co., Ltd.
No.1, Lane 160, Section 2,
Tan-Fu Road
Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005
The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.
FDA Recall
Terminated
·Tung Keng Enterprise Co., Ltd.
No.1, Lane 160, Section 2,
Tan-Fu Road
Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code KPR·July 12, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024