795 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
FDA Enforcement
Class II
·Terminated·Dokitz NovoSci·November 12, 2014
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
FDA Recall
Terminated
·Dokitz NovoSci·Product code DTL·September 18, 2014
Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
FDA Recall
Terminated
·Vistakon·Product code LPM·July 16, 2010
Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator. Amstech Incorporated, Alpharetta, GA 30022. Targeting, detecting heated areas, searches.
FDA Recall
Terminated
·Amstech Incorporated·Product code REP·August 17, 2010
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
FDA Recall
Terminated
·Fresenius Medical Care North America·Product code FKP·November 20, 2009
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
FDA Recall
Terminated
·Cook Inc.·Product code MIH·January 16, 2020
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
FDA Recall
Terminated
·Fresenius Medical Care North America·Product code KDI·November 20, 2009
Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA
FDA Recall
Terminated
·Fresenius Medical Care North America·Product code KPO·November 20, 2009
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
FDA Recall
Terminated
·Fresenius Medical Care North America·Product code FKP·November 20, 2009
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPS·September 3, 2004
Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
FDA Recall
Terminated
·C P Medical Inc.·Product code GAR·June 29, 2011
Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FFX·February 23, 2009
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
FDA Recall
Terminated
·BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico·Product code LPB·October 2, 2008
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·November 7, 2013
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
FDA Recall
Terminated
·BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico·Product code LPB·October 2, 2008
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LGW·May 3, 2016
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
FDA Recall
Terminated
·Safe N Simple, LLC·Product code NEC·June 18, 2012
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
FDA Recall
Terminated
·Arrow International Inc·Product code DYB·March 25, 2011
ProxiDiagnost N90, UDI 706100
FDA Recall
Terminated
·Philips North America, LLC·Product code JAA·April 23, 2020
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
FDA Recall
Terminated
·Philips North America, LLC·Product code JAA·June 2, 2020