| device-recall:cfres:162008 |
rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. |
Official recall number · Z-2717-2018 |
Under Investigation by firm |
| device-recall:cfres:162012 |
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. |
Official recall number · Z-2720-2018 |
Under Investigation by firm |
| device-recall:cfres:157403 |
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening. |
Official recall number · Z-2756-2017 |
Packaging |
| device-recall:cfres:177019 |
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI |
Official recall number · Z-0345-2020 |
Under Investigation by firm |
| device-recall:cfres:142341 |
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. |
Official recall number · Z-0602-2016 |
Device Design |
| device-recall:cfres:215937 |
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. |
Official recall number · Z-0021-2026 |
Process control |
| device-recall:cfres:166539 |
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use. |
Official recall number · Z-3011-2018 |
Under Investigation by firm |
| device-recall:cfres:124614 |
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530 |
Official recall number · Z-1010-2014 |
Packaging |
| device-recall:cfres:120648 |
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use. |
Official recall number · Z-2096-2013 |
Error in labeling |
| device-recall:cfres:121671 |
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. |
Official recall number · Z-2260-2013 |
Packaging |
| device-recall:cfres:121947 |
chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. |
Official recall number · Z-0087-2014 |
Nonconforming Material/Component |
| device-recall:cfres:124436 |
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes |
Official recall number · Z-0539-2014 |
Unknown/Undetermined by firm |
| device-recall:cfres:123218 |
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose |
Official recall number · Z-0488-2014 |
Device Design |
| device-recall:cfres:126016 |
Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 |
Official recall number · Z-1380-2014 |
No Marketing Application |
| device-recall:cfres:125969 |
Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 |
Official recall number · Z-1344-2014 |
No Marketing Application |
| device-recall:cfres:126155 |
Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 |
Official recall number · Z-1410-2014 |
No Marketing Application |
| device-recall:cfres:125989 |
Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054 |
Official recall number · Z-1364-2014 |
No Marketing Application |
| device-recall:cfres:126024 |
Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054 |
Official recall number · Z-1387-2014 |
No Marketing Application |
| device-recall:cfres:125988 |
Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054 |
Official recall number · Z-1363-2014 |
No Marketing Application |
| device-recall:cfres:125979 |
Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054 |
Official recall number · Z-1354-2014 |
No Marketing Application |
| device-recall:cfres:125991 |
Tramadol Strip; LumiQuick. Santa Clara, CA 95054 |
Official recall number · Z-1366-2014 |
No Marketing Application |
| device-recall:cfres:126158 |
Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 |
Official recall number · Z-1413-2014 |
No Marketing Application |
| device-recall:cfres:134596 |
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . |
Official recall number · Z-1541-2015 |
Labeling False and Misleading |
| device-recall:cfres:131840 |
PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. |
Official recall number · Z-0754-2015 |
Error in labeling |
| device-recall:cfres:131762 |
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. |
Official recall number · Z-0694-2015 |
Error in labeling |
