Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Siemens Healthcare Diagnostics
Class I - Dangerous
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Bivona Uncuffed Wire Endotracheal Tubes,
Smiths Medical ASD
Class I - Dangerous
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.
Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
W L Gore & Associates
Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
Implant Resource
Class I - Dangerous
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Foundation Kit
Stradis Medical, LLC
Class I - Dangerous
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Limacorporate S.p.A
Class I - Dangerous
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Due to misbranded products shipped to customers.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical ASD
Class I - Dangerous
The labeling was missing information on sterilization and prohibition of reuse.
IUD Insertion Pack
Stradis Medical, LLC
Class I - Dangerous
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
6.5MMX165MM CANNULATED SCREW
Smith & Nephew
Class I - Dangerous
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Due to misbranded products shipped to customers.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.