Class I - Dangerous
Removing parts for safety reasons due to possible breakage.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
James Leckey Design
Class I - Dangerous
Due to a failure of the welds, the casters detached from the rear legs of the walker.
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare
Class I - Dangerous
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Class I - Dangerous
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Infusion Pump Repair
Class I - Dangerous
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
STEP-HAR MEDICAL
Class I - Dangerous
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Class I - Dangerous
ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.
Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
Class I - Dangerous
failed rivet at the chafe tab of arm sling.
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Class I - Dangerous
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
Class I - Dangerous
failed rivet at the chafe tab of arm sling.
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Baxter Healthcare
Class I - Dangerous
Potentially defective component in the AC power adapter which may fail over time.
Class I - Dangerous
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Class I - Dangerous
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.