P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Fort Defiance Industries
Class I - Dangerous
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
CADD Administration Sets, Model #21-7346-24
Smiths Medical ASD
Class I - Dangerous
Product may have been manufactured with an air filter assembled in an incorrect orientation.
Class I - Dangerous
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
National Distribution & Contracting
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
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek USA
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
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.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Thoraguard Chest Tube Kit, 20 Fr
Centese
Class I - Dangerous
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
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
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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
Class I - Dangerous
Engraving on implants may not match what is listed on the pouch labels.
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
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
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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
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 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Red Medical Supplies
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
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.