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
🔪
Surgical Instruments
🏥 Medical Devices • 7,015 recalls
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.
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Merit Medical Systems
Class I - Dangerous
Supplier manufacturing defect with the syringe plunger tip.
Class I - Dangerous
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Class I - Dangerous
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Intuitive Surgical
Class I - Dangerous
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.
Class I - Dangerous
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).
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
Megadyne Medical Products
Class I - Dangerous
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.
Class I - Dangerous
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.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Smiths Medical ASD
Class I - Dangerous
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.
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.