Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Edwards Lifesciences
Class I - Dangerous
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Intuitive Surgical
Class I - Dangerous
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Wright Medical Technology
Class I - Dangerous
The tibial tray lock detail is oversized (larger than specification).
Class I - Dangerous
A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Wright Medical Technology
Class I - Dangerous
The tibial tray lock detail is oversized (larger than specification).
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
ZOLL Circulation
Class I - Dangerous
Due to increase in Li-Ion Battery failures
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens Medical Solutions USA
Class I - Dangerous
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Class I - Dangerous
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Class I - Dangerous
Incidents of device splitting or detaching during use
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
Class I - Dangerous
Incidents of device splitting or detaching during use
Class I - Dangerous
Incidents of device splitting or detaching during use
Class I - Dangerous
Product pouch label does not match up with carton label
Class I - Dangerous
Incidents of device splitting or detaching during use