127 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
FDA Recall
Terminated
·Product code RCG·October 27, 2017
American Science & Engineering Inc,Gemini Cabinet X-ray system.
FDA Recall
Terminated
·American Science & Engineering, Inc.·Product code RCG·May 22, 2015
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
FDA Enforcement
Class II
·Terminated·Bard Access Systems Inc.·May 26, 2021
REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.
FDA Enforcement
Class II
·Terminated·Bard Access Systems Inc.·May 26, 2021
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Recall
Terminated
·Bard Access Systems·Product code LJS·May 27, 2015
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Recall
Terminated
·Bard Access Systems·Product code LJS·May 27, 2015
Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent & ACG knee system. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
FDA Recall
Terminated
·Bard Access Systems Inc.·Product code LJS·April 7, 2021
REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.
FDA Recall
Terminated
·Bard Access Systems Inc.·Product code LJS·April 7, 2021
Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006
Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy 1503-3006-000 Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·January 27, 2016
Disney Baby Soft Cool Ring Teether Style # Y1470
FDA Recall
Terminated
·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006
Disney Baby Soft Cool Ring Teether Style # Y1490
FDA Recall
Terminated
·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006
Sesame Beginnings Chill & Chew Teether Style #Y3095
FDA Recall
Terminated
·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006
Disney Days Hunny Cool Ring Teether Style # Y1447
FDA Recall
Terminated
·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006