Year

2020 Product Recalls

3,943 product recalls issued in 2020 across CPSC, FDA, and USDA datasets.

3,943 recalls
High RiskFDA
Icu Medical, Inc.
83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Orthopediatrics Corp
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilizatio...
Medical Devices·73 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)1088...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 mul...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow di...
Medical Devices·350,779 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifo...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case;...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01)10887709098937(1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical C...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)108406190612...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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. UDI...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)2...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system int...
Medical Devices·8 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow d...
Medical Devices·27,341 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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,...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 c...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)108877090...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)2...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. Th...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 pou...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)10887709079...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Golden Technologies, Inc.
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising f...
Medical Devices·251 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotat...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)108877...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)10840619076...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)2502...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)10887709062...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)1...
Surgical Devices·1 affected·Jul 6, 2020