Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Baxter Floor mounting column TruSystem 7500, Product Code 1717021
Baxter Healthcare
Class I - Dangerous
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Baxter Floor mounting column TS 7500 U, Product Code 1730732
Baxter Healthcare
Class I - Dangerous
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Baxter Mobile column TruSystem 7500, Product Code 1717023
Baxter Healthcare
Class I - Dangerous
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class I - Dangerous
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Class I - Dangerous
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
CYSTO , Model No SACY80R
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Class I - Dangerous
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
American Contract Systems
Class I - Dangerous
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.