Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
Class I - Dangerous
There is a potential for blockage of the Hub Attachment Tube.
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Class I - Dangerous
Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
Class I - Dangerous
Microscopic tears of the sterile pouch may compromise sterility
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Palodex Group Oy
Class I - Dangerous
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
Class I - Dangerous
The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Arrow International
Class I - Dangerous
Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
Class I - Dangerous
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Teleflex Medical
Class I - Dangerous
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Teleflex Medical
Class I - Dangerous
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.