Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
Open Shoulder, LWOS39L; Medical convenience kit
American Contract Systems
Class I - Dangerous
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Boston Scientific
Class I - Dangerous
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Class I - Dangerous
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare
Class I - Dangerous
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I - Dangerous
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Boston Scientific
Class I - Dangerous
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Safeguard US Operating
Class I - Dangerous
Incorrect expiration date.
Class I - Dangerous
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
HAWK Warming Grid, Item Number: 59-300
Safeguard US Operating
Class I - Dangerous
Incorrect expiration date.
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Class I - Dangerous
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Class I - Dangerous
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Class I - Dangerous
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Class I - Dangerous
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Class I - Dangerous
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.