Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 200 of 548
FDA Devices Critical Oct 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Baxter Healthcare Corporation
FDA Devices Critical Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 …
Medtronic Vascular
FDA Devices Critical Oct 28, 2020
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK4…
Stryker Neurovascular
FDA Devices Moderate Oct 28, 2020
6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)455…
ICU Medical, Inc.
FDA Devices Critical Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind ba…
Medtronic Vascular
FDA Devices Moderate Oct 28, 2020
6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)25010…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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 case.UDI:…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign…
GE Healthcare, LLC
FDA Devices Moderate Oct 28, 2020
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline ph…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 28, 2020
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligatio…
Ethicon, Inc.
FDA Devices Moderate Oct 28, 2020
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 u…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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. UDI:(01)10887709051967(17)…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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. UDI:(01)10840619076174(17)25020…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimu…
Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Oct 28, 2020
9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(0…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces an…
Bien-Air Surgery Sa
FDA Devices Moderate Oct 28, 2020
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)25020…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating …
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia a…
Quidel Corporation
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)1088770906506…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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. UDI:(01)1088770907…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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. UDI:(0…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(…
ICU Medical, Inc.
FDA Devices Critical Oct 28, 2020
Langston Dual Lumen Catheter
Vascular Solutions, Inc.
FDA Devices Moderate Oct 28, 2020
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF …
Encore Medical, LP
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)108877090…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; …
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)24…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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 pouch, 25…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
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, Rotating…
ICU Medical, Inc.
FDA Devices Critical Oct 28, 2020
Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation
FDA Devices Moderate Oct 28, 2020
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; …
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-…
Olympus Corporation of the Americas
FDA Devices Moderate Oct 28, 2020
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well …
Maquet Cardiovascular Us Sales, Llc