🏥 Medical Devices Class I - Dangerous
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
🏥 Medical Devices Class I - Dangerous
Under certain conditions, there is a risk for a false negative result.
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Red Medical Supplies
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
🏥 Medical Devices Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for false positive results.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for false positive results.
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Red Medical Supplies
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Red Medical Supplies
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
W L Gore & Associates
🏥 Medical Devices Class I - Dangerous
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for false positive results.
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Philips North America
🏥 Medical Devices Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
🏥 Medical Devices Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
🏥 Medical Devices Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
🏥 Medical Devices Class I - Dangerous
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
🏥 Medical Devices Class I - Dangerous
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds