Olympus Corporation of the Americas - EVIS EXERA BFXT160 Bronchofibervideoscope - Class 2 Recall
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts

Roche Molecular Systems, Inc. - cobas SARSCoV2 & Influenza A/B Test - Class 2 Recall
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Class 2 Recall
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts

Argon Medical Devices, Inc - Scorpion Portal Vein Access Set - Class 2 Recall
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts

M.D.L. S.r.l. - Harvest, Illy, Jamblu, OsteoJ, PenBone, Pickup, Pressto - Class 2 Recall
Bone Marrow Transplantation biopsy needle (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

M.D.L. S.r.l. - Cytocut - Class 2 Recall
Aspirated Cyto-Histological Biopsy needle (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

M.D.L. S.r.l. - Automark, Mark, Markslim, Repomark - Class 2 Recall
Mammary Nodules Localization (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

M.D.L. S.r.l. - Soft Tissue Biopsy - Class 2 Recall
General Manual surgical instrument (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

M.D.L. S.r.l. - Soft Tissue Biopsy - Class 2 Recall
Soft Tissue Biopsy Needles (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

Ad-Tech Medical Instrument Corporation - TECHATTACH Connection System Cable - Class 2 Recall
Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

Ad-Tech Medical Instrument Corporation - Lightweight CABRIO Cable - Class 2 Recall
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

Ad-Tech Medical Instrument Corporation - Lightweight CABRIO Cable - Class 2 Recall
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2021 Category: Medical Devices Source Type: alerts

Mac Medical Supply Co Inc - Multipe (see code info) - Class 1 Recall
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Pellet) - Class 2 Recall
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Swab) - Class 2 Recall
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Paragon 28, Inc. - Phantom Hindfoot TTC/TC Nail System - Class 2 Recall
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Philips Ultrasound Inc - Philips Afiniti Diagnostic Ultrasound Systems - Class 2 Recall
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Philips Ultrasound Inc - Philips EPIQ Diagnostic Ultrasound Systems - Class 2 Recall
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts

Arjohuntleigh Magog, Inc. - Maxi Sky 1000 (Arjo) and V10 (BHM) - Class 2 Recall
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2021 Category: Medical Devices Source Type: alerts

Welch Allyn Inc - Braun - Class 2 Recall
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2021 Category: Medical Devices Source Type: alerts

Heartware, Inc. - Medtronic HVAD Pump Implant Kits - Class 2 Recall
Medtronic HVAD Pump Implant Kits (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2021 Category: Medical Devices Source Type: alerts

Leica Microsystems, Inc. - BOND - Class 2 Recall
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2021 Category: Medical Devices Source Type: alerts

Quidel Corporation - Class 2 Recall
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Cordis Corporation - 5f UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL - Class 1 Recall
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Cordis Corporation - 5F SUPER TORQUE PIG PIGTAIL SPECIAL - Class 1 Recall
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Cordis Corporation - SUPER TORQUE MB 5F PIG - Class 1 Recall
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Cordis Corporation - SUPER TORQUE MB 5F PIG - Class 1 Recall
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Cordis Corporation - SUPER TORQUE MB 5F PIG - Class 1 Recall
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2021 Category: Medical Devices Source Type: alerts

Philips North America Llc - Philips Azurion 7 M20 - Class 2 Recall
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Philips North America Llc - Philips Allura Xper FD20 - Class 2 Recall
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies ...
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Philips North America Llc - Philips Allura Xper FD20/20 - Class 2 Recall
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis." "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies ...
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Cypress Medical Products LLC - McKesson Lap Sponge - Class 2 Recall
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - ACUSON Juniper ultrasound imaging system - Class 2 Recall
ACUSON Juniper Diagnostic Ultrasound System (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Abbott Laboratories - Alinity ciseries System Control Module (SCM) - Class 2 Recall
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

Accora Inc - Configura Advance Chair - Class 2 Recall
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-2...
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

Cellex - Cellex qSARSCov2 Antigen Rapid Test - Class 2 Recall
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented - Class 2 Recall
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD SmartSite Bag Access Device - Class 2 Recall
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD ADDON Burette Set V/NV NeedleFree Valve - Class 2 Recall
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector - Class 2 Recall
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 N...
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Extension Set SMALLBORE Tubing SmartSite VALVE - Class 2 Recall
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD Sma...
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Syringe Set 20 DP MIC TBG 0.2MF CKV AntiSiphon SmartSite VLV Sensing Disc - Class 2 Recall
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703; (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED - Class 2 Recall
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) Sma - Class 2 Recall
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsit...
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES - Class 2 Recall
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Gravity IV Set 3port Closed Manifold Back Check Valve 3 NeedleFree Ysites - Class 2 Recall
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD SmartSite 'Y' Extension Set 2 NeedleFree Valves - Class 2 Recall
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD SmartSite Bag Access Device NeedleFree Valve - Class 2 Recall
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV - Class 2 Recall
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts

CAREFUSION - BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER - Class 2 Recall
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2021 Category: Medical Devices Source Type: alerts