🏥 Medical Devices • 6,839 recalls
Civco Medical Instruments Co.
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Civco Medical Instruments Co.
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
Medical Components, Inc
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
Merit Medical Systems
Supplier manufacturing defect with the syringe plunger tip.
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Intuitive Surgical
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Megadyne Medical Products
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Smiths Medical ASD
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.