Alcon Custom Ophthalmic Surgical Procedure Packs
Alcon Research
Class I - Dangerous
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Class I - Dangerous
Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.
Class I - Dangerous
Potential for open seal on sterile product
Class I - Dangerous
There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.
Teleflex is recalling this product due to a lack of assurance of sterility.
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Bard Peripheral Vascular
Class I - Dangerous
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Epimed International
Class I - Dangerous
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Class I - Dangerous
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Class I - Dangerous
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Class I - Dangerous
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Class I - Dangerous
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Class I - Dangerous
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Medtronic Vascular
Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Medtronic Vascular
Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Medtronic Vascular
Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Medtronic Vascular
Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
Class I - Dangerous
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Class I - Dangerous
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Class I - Dangerous
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.