JAGTOME RX 44-30-260-035 Material Number: M00573060
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
JAGTOME RX 39-30-450-025 Material Number: M00573110
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 44-30-450-035 Material Number: M00573070
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 44-20-450-035 Material Number: M00573050
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
Class I - Dangerous
Failed stability specifications for reagent kits that may result in false negative test results.
JAGTOME RX 39-30-260-025 Material Number: M00573100
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LINQ II Insertable Cardiac Monitor
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Devices may lose functionality due to susceptibility to moisture ingress.
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Bio-Rad Laboratories
Class I - Dangerous
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Bio-Rad Laboratories
Class I - Dangerous
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class I - Dangerous
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
JAGTOME RX 39-20-260-025 Material Number: M00573080
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
Class I - Dangerous
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
DREAMTOME 49-20MM/450CM Material Number: M00584020
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach