IceSeed" 1.5 MRI Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
All Recalls
95,114 total recalls in our database
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.
ADVIA 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): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
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.
🏥 Medical Devices Class I - Dangerous
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
🏥 Medical Devices Class I - Dangerous
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
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.
IceFORCE" 2.1 CX 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.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
🏥 Medical Devices Class I - Dangerous
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is a potential software error during programming.
🏥 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
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.