🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.
🏥 Medical Devices Class I - Dangerous
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
🏥 Medical Devices Class I - Dangerous
Multiple lots being recalled due to a product design issue
🏥 Medical Devices Class I - Dangerous
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
🏥 Medical Devices Class I - Dangerous
Sterile introducer sheath set manufactured under one lot with different expiration dates.
🏥 Medical Devices Class I - Dangerous
Suspect poor weld on back KD bar.
🏥 Medical Devices Class I - Dangerous
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Smith & Nephew
🏥 Medical Devices Class I - Dangerous
The products were improperly heat treated.
🏥 Medical Devices Class I - Dangerous
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
🏥 Medical Devices Class I - Dangerous
FDA revocation of the Emergency Use Authorization due to performance issues
🏥 Medical Devices Class I - Dangerous
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
🏥 Medical Devices Class I - Dangerous
FDA revocation of the Emergency Use Authorization due to performance issues
🏥 Medical Devices Class I - Dangerous
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
🏥 Medical Devices Class I - Dangerous
The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.
🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
🏥 Medical Devices Class I - Dangerous
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
🏥 Medical Devices Class I - Dangerous
Modular Junction Box (MJB) cables can melt and affect the bed functionality.