Ethicon Endo-Surgery HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm recall — FDA Z-2049-2018
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Complete FDA and NHTSA recall records dated in June 2018.
These records include useful source details for the selected month.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using…
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Product sterility may be compromised due to unsealed packaging.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
The device is equipped with a dial that has an inaccurate flow rate indicator.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.