Medical DeviceDec 7, 2016
Elekta Monaco RTP System; Used to make treatment plans for patients with prescriptions for recall — FDA Z-0660-2017
Incorrect Dose when using the reset function.
Class IIFDA: TerminatedElekta, Inc.
Latest records
Latest recalls — page 1751
The newest recall records with useful source details are listed here.
Medical DeviceDec 7, 2016
Elekta Monaco TRP System The Monaco system is used to make treatment plans for patients with recall — FDA Z-0668-2017
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceDec 7, 2016
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile recall — FDA Z-0658-2017
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Class IIFDA: TerminatedConforMIS, Inc.
Medical DeviceDec 7, 2016
Spectranetics Turbo Elite Atherectomy Catheter recall — FDA Z-0661-2017
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially…
Class IIFDA: TerminatedSpectranetics Corporation
Medical DeviceDec 7, 2016
Teleflex Medical OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow recall — FDA Z-0678-2017
Sterility: Due to a potential incomplete seal on the outer sterile package.
Class IIFDA: TerminatedTeleflex Medical
Medical DeviceDec 7, 2016
Hamilton Medical Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is recall — FDA Z-0666-2017
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Class IIFDA: TerminatedHamilton Medical, Inc.
Medical DeviceDec 7, 2016
Spectranetics Bridge Occlusion Balloon recall — FDA Z-0663-2017
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially…
Class IIFDA: TerminatedSpectranetics Corporation
Medical DeviceDec 7, 2016
Roche Diagnostics Operations MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S recall — FDA Z-0673-2017
Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceDec 7, 2016
Teleflex Medical ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow recall — FDA Z-0677-2017
Sterility: Due to a potential incomplete seal on the outer sterile package.
Class IIFDA: TerminatedTeleflex Medical
Medical DeviceDec 7, 2016
MicroPort Orthopedics Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706 recall — FDA Z-0685-2017
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and…
Class IIIFDA: TerminatedMicroPort Orthopedics Inc.
Medical DeviceDec 7, 2016
Terumo BCT Adiprep Adipose Transfer System recall — FDA Z-0674-2017
Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator…
Class IIFDA: TerminatedTerumo BCT, Inc.
Medical DeviceDec 7, 2016
Merge FlexConnect software, a component of Merge LIS recall — FDA Z-0664-2017
Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceDec 7, 2016
MicroPort Orthopedics Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019 recall — FDA Z-0689-2017
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and…
Class IIIFDA: TerminatedMicroPort Orthopedics Inc.
Medical DeviceDec 7, 2016
Greatbatch Medical Greatbatch, Offset Cup Impactor with the following Parts and Catalogue # recall — FDA Z-0367-2017
On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the…
Class IFDA: TerminatedGreatbatch Medical
Medical DeviceDec 7, 2016
MicroPort Orthopedics Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF recall — FDA Z-0684-2017
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and…
Class IIIFDA: TerminatedMicroPort Orthopedics Inc.
Medical DeviceDec 7, 2016
Siemens Medical Solutions USA Z6Ms transesophageal transducers used on ACUSON SC2000 recall — FDA Z-0667-2017
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 7, 2016
Teleflex Medical ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only recall — FDA Z-0675-2017
Sterility: Due to a potential incomplete seal on the outer sterile package.
Class IIFDA: TerminatedTeleflex Medical
FoodDec 7, 2016
Kuster's Fata's Best Monterey Jack Feather Shred Shredded Cheese, 5 lb recall — FDA F-0437-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Kuster's Nor-Tech Dairy Mozz/Muenster/Prov Feather Shred Shredded recall — FDA F-0439-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Kuster's Fata's Best Mozzarella Muenster Provolone Feather Shred recall — FDA F-0436-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Kuster's 5 lb recall — FDA F-0434-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Kuster's A New Dairy PepperJack 3/4" Cubed Cheese, 5 lb recall — FDA F-0441-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Kuster's Fata's Best Four Blend Feather Shred Shredded Cheese, 5 lb recall — FDA F-0435-2017
Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria…
Class IFDA: TerminatedKuster's Inc.
FoodDec 7, 2016
Mel-O Cream Donuts International Hy Vee Long Johns recall — FDA F-0546-2017
Human fingertip found in product filling line.
Class IIFDA: TerminatedMel-O Cream Donuts International, Inc.
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