Medical DeviceJan 18, 2017
ICU Medical Tego Connector, Item No recall — FDA Z-0988-2017
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
Class IIFDA: TerminatedICU Medical, Inc.
Latest records
Latest recalls — page 1716
The newest recall records with useful source details are listed here.
Medical DeviceJan 18, 2017
GE OEC Medical Systems OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to recall — FDA Z-0973-2017
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent…
Class IIFDA: TerminatedGE OEC Medical Systems, Inc.
Medical DeviceJan 18, 2017
Siemens Medical Solutions USA Biograph mCT S(64)-4R, Material Number 10248672 The Siemens recall — FDA Z-0996-2017
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.
Medical DeviceJan 18, 2017
C.R. Bard SURESTEP Tray, BARDEX I.C recall — FDA Z-0967-2017
The product contained a latex catheter instead of a silicone catheter.
Class IIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceJan 18, 2017
ICU Medical 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating recall — FDA Z-0980-2017
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJan 18, 2017
Bard Access Systems StatLock PICC Plus Crescent Foam recall — FDA Z-0981-2017
Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers…
Class IIFDA: TerminatedBard Access Systems
Medical DeviceJan 18, 2017
In2Bones, SAS NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois recall — FDA Z-0953-2017
Dimensional non-conformity of the thread on the screw head.
Class IIFDA: TerminatedIn2Bones, SAS
Medical DeviceJan 18, 2017
Elekta Monaco RTP System Product Usage: Used to make treatment plans for patients with recall — FDA Z-1009-2017
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceJan 18, 2017
Philips Medical Systems (Cleveland) Brilliance iCT Product Usage: Computed Tomography X-ray recall — FDA Z-1004-2017
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJan 18, 2017
In2Bones, SAS SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du recall — FDA Z-0952-2017
Dimensional non-conformity of the thread on the screw head.
Class IIFDA: TerminatedIn2Bones, SAS
Medical DeviceJan 18, 2017
Bard Access Systems SafeStep Huber Needle Set with Y-Injection Site recall — FDA Z-0986-2017
Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices…
Class IIFDA: TerminatedBard Access Systems
Medical DeviceJan 18, 2017
Siemens Medical Solutions USA Biograph mCT S(40)-4R, Material Number 10248671 The Siemens recall — FDA Z-0995-2017
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.
Medical DeviceJan 18, 2017
Beckman Coulter DxH 600 Coulter Cellular Analysis System, Catalog No recall — FDA Z-1014-2017
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceJan 18, 2017
Medtronic Navigation AxIEM Touch N Go Pointer Probe recall — FDA Z-1007-2017
Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using…
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceJan 18, 2017
Acumed OPT Croutons is a synthetic bone substitute designed for the repair of bony defects recall — FDA Z-1019-2017
OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive…
Class IIFDA: TerminatedAcumed LLC
Medical DeviceJan 18, 2017
HEALTH ROBOTICS S.R.L i.v. Station and i.v. Station ONCO Automated Drug Compounding System recall — FDA Z-0989-2017
The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.
Class IIFDA: TerminatedHEALTH ROBOTICS S.R.L.
Medical DeviceJan 18, 2017
Siemens Medical Solutions USA Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The recall — FDA Z-0999-2017
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.
Medical DeviceJan 18, 2017
symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136 recall — FDA Z-1010-2017
Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
Class IIFDA: TerminatedSymmetry Surgical, Inc.
Medical DeviceJan 18, 2017
Siemens Medical Solutions USA Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The recall — FDA Z-0998-2017
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.
FoodJan 18, 2017
Magic Gourmet Trading Koi Palace Mini Moon Cake: Luxury Single Mooncake - Mini White recall — FDA F-0868-2017
Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen…
Class IIFDA: TerminatedMagic Gourmet Trading Inc.
FoodJan 18, 2017
PIAZZA PRODUCE Italian Herb seasoning, 6 lb plastic pail, product number recall — FDA F-1099-2017
Product labeling does not contain a listing of ingredients. Undeclared Soybean oil.
Class IIFDA: TerminatedPIAZZA PRODUCE, Inc.
FoodJan 18, 2017
PIAZZA PRODUCE Onion salt, 9 lb plastic gallon, product number 65845 recall — FDA F-1102-2017
Product labeling does not contain a listing of ingredients.
Class IIIFDA: TerminatedPIAZZA PRODUCE, Inc.
FoodJan 18, 2017
All American Seasonings French Onion Seasoning ASI recall — FDA F-1211-2017
Products have been recalled due to potential for Salmonella contamination.
Class IFDA: TerminatedAll American Seasonings, Inc.
FoodJan 18, 2017
PIAZZA PRODUCE Quebec Steak seasoning, 1.5 lb plastic jar, product number recall — FDA F-1105-2017
Product labeling does not contain a listing of ingredients. Undeclared Soybean oil.
Class IIFDA: TerminatedPIAZZA PRODUCE, Inc.
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