Is My Product Recalled? Free U.S. Recall Search

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GE Healthcare, LLC: SIGNA Voyager nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDAAug 26, 2021Nationwide• GE Healthcare, LLC
GE Healthcare, LLC: Optima MR450w 1.5T nuclear magnetic resonance imaging sy...
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR750w 3.0T nuclear magnetic resonance imaging...
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDAAug 26, 2021Nationwide• GE Healthcare, LLC

Heartware, Inc.: Medtronic HVAD Pump Implant Kits
There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
FDAAug 6, 2021IN• Heartware, Inc.

CAREFUSION: BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG A...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartS...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, R...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALV...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

GE Healthcare, LLC: Flow sensors that may be installed in the following GEHC ...
Laceration Risk
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
FDAAug 2, 2021Nationwide• GE Healthcare, LLC

CAREFUSION: BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVe...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

GE Healthcare, LLC: Flow sensors kept as stand-alone user replaceable spare p...
Laceration Risk
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
FDAAug 2, 2021Nationwide• GE Healthcare, LLC

CAREFUSION: BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Sm...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD Gravity IV Set 3-port Closed Manifold Back Check Valve...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES ...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF:...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

CAREFUSION: BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/...
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDAAug 2, 2021Nationwide• CAREFUSION

Roche Diabetes Care, Inc.: Accu-Chek SmartView Test Strip, Blood Glucose Monitoring ...
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
FDAJul 28, 2021Nationwide• Roche Diabetes Care, Inc.