FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
FDA Device · Class I · 2020-10-28 · Baxter Healthcare - 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotatin…
FDA Device · Class II · 2020-10-28 · Icu Medical - RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer,…
FDA Device · Class II · 2020-10-28 · Icu Medical - 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Langston Dual Lumen Catheter
FDA Device · Class I · 2020-10-28 · Vascular Solutions - 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per…
FDA Device · Class II · 2020-10-28 · Icu Medical - Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 006139947…
FDA Device · Class I · 2020-10-28 · Medtronic Vascular - TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch…
FDA Device · Class II · 2020-10-28 · Icu Medical - 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Device · Class I · 2020-10-28 · Baxter Healthcare - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Device · Class I · 2020-10-28 · Baxter Healthcare - Langston Dual Lumen Catheter
FDA Device · Class I · 2020-10-28 · Vascular Solutions - 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold,…
FDA Device · Class II · 2020-10-28 · Icu Medical - 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches pe…
FDA Device · Class II · 2020-10-28 · Icu Medical - 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashki…
FDA Device · Class I · 2020-10-28 · Medtronic Vascular - 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)108877090…
FDA Device · Class II · 2020-10-28 · Icu Medical - 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical intervention…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales - Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN)…
FDA Device · Class II · 2020-10-28 · Boston Scientific - 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,…
FDA Device · Class II · 2020-10-28 · Ge Healthcare - TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave
FDA Device · Class II · 2020-10-28 · Icu Medical - 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR
FDA Device · Class II · 2020-10-28 · Icu Medical - 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per…
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
FDA Device · Class II · 2020-10-28 · Smith And Nephew - PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical in…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales - 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch,…
FDA Device · Class II · 2020-10-28 · Icu Medical - AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical should…
FDA Device · Class II · 2020-10-28 · Encore Medical - TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximati…
FDA Device · Class II · 2020-10-28 · Ethicon - TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the ligh…
FDA Device · Class II · 2020-10-28 · Bien Air Surgery - 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
FDA Device · Class II · 2020-10-28 · Smith And Nephew - TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
FDA Device · Class II · 2020-10-28 · Smith And Nephew - NanoClave Connector
FDA Device · Class II · 2020-10-28 · Icu Medical - 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue…
FDA Device · Class II · 2020-10-28 · Icu Medical - Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one…
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashki…
FDA Device · Class I · 2020-10-28 · Medtronic Vascular - Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy…
FDA Device · Class II · 2020-10-28 · Bien Air Surgery - 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coa…
FDA Device · Class II · 2020-10-28 · Encore Medical - 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, R…
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,…
FDA Device · Class II · 2020-10-28 · Ge Healthcare - TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive han…
FDA Device · Class II · 2020-10-28 · Bien Air Surgery - ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks,…
FDA Device · Class II · 2020-10-28 · Icu Medical - MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave
FDA Device · Class II · 2020-10-28 · Icu Medical - 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps…
FDA Device · Class II · 2020-10-28 · Icu Medical - 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch,…
FDA Device · Class II · 2020-10-28 · Icu Medical - Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains in…
FDA Device · Class II · 2020-10-28 · Ge Healthcare - OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
FDA Device · Class II · 2020-10-28 · Smith And Nephew - HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
FDA Device · Class II · 2020-10-28 · Smith And Nephew - OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 7 IN(18 cm)APPX 1.2ml
FDA Device · Class II · 2020-10-28 · Icu Medical - 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
FDA Device · Class II · 2020-10-28 · Smith And Nephew - HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
FDA Device · Class II · 2020-10-28 · Smith And Nephew
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