Class I - Dangerous
Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
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
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