Class I - Dangerous
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Strep A Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Philips Medical Systems
Class I - Dangerous
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Draeger Medical Systems
Class I - Dangerous
The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products
Class I - Dangerous
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.