🏥 Medical Devices Class I - Dangerous
Device has the potential for fracture during use.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
🏥 Medical Devices Class I - Dangerous
There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
IceRod" 1.5 i-Thaw" Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
🏥 Medical Devices Class I - Dangerous
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
IceSeed" 1.5 90¿ Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
IceSeed" 1.5 MRI Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Nova Ortho-Med
🏥 Medical Devices Class I - Dangerous
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
GA HEALTH COMPANY LIMITED
🏥 Medical Devices Class I - Dangerous
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
IceSphere" 1.5 CX 90¿ Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
IceSphere" 1.5 Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
IceSphere" 1.5 S 90¿ Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.