Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
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.
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.
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
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.
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.
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.
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
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.
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
High RiskFDA
Icu Medical, Inc.
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)108406190...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 ca...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)1088770907550...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Arrow International Inc
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly t...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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 p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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)10840619...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clam...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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(1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
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...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)25...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blu...
Surgical Devices·1,100 affected·Jul 1, 2020
High RiskFDA
Teleflex Medical Inc
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the...
Medical Devices·1,812 affected·Jun 30, 2020
High RiskFDA
Emd Serono, Inc.
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., R...
Injectable Drugs·30,756 affected·Jun 29, 2020
High RiskFDA
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patien...
Medical Devices·3 affected·Jun 29, 2020
High RiskFDA
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to hel...
Medical Devices·12 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff re...
Surgical Devices·137 affected·Jun 24, 2020
High RiskFDA
Arthrex, Inc.
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone...
Medical Devices·28 affected·Jun 24, 2020