🏥 Medical Devices Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
All Recalls
95,018 total recalls in our database
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
National Distribution & Contracting
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Philips North America
🏥 Medical Devices Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
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.
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Engraving on implants may not match what is listed on the pouch labels.
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
ELEKTA SOLUTIONS AB
🏥 Medical Devices Class I - Dangerous
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
🏥 Medical Devices Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Thoraguard Chest Tube Kit, 20 Fr
Centese
🏥 Medical Devices Class I - Dangerous
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems
🏥 Medical Devices Class I - Dangerous
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
🏥 Medical Devices Class I - Dangerous
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
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
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Engraving on implants may not match what is listed on the pouch labels.
🏥 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
🏥 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.