Medical DeviceSep 4, 2019
Phadia Ab Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated recall — FDA Z-2397-2019
code 7-102 Liquid Sensor Error
Class IIFDA: TerminatedPhadia Ab
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 69
Records are ordered by the best available source date.
Medical DeviceSep 4, 2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 recall — FDA Z-2361-2019
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceSep 4, 2019
Elekta Monaco Radiation Treatment Planning System (RTP) System recall — FDA Z-2409-2019
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded recall — FDA Z-2381-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Siemens Medical Solutions USA SOMATOM go.All; Models #11061630 Product Usage: This computed recall — FDA Z-2402-2019
The injector holder could potentially fall off together with the injector and the storage box.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet recall — FDA Z-2373-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Stryker GmbH Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is recall — FDA Z-2421-2019
The seal integrity of the sterile bag containing the kits may be compromised.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceSep 4, 2019
Ad-Tech Medical Instrument Skull Anchor Bolts recall — FDA Z-2408-2019
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are…
Class IIFDA: TerminatedAd-Tech Medical Instrument Corporation
Medical DeviceSep 4, 2019
Stryker GmbH Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system recall — FDA Z-2422-2019
The seal integrity of the sterile bag containing the kits may be compromised.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet recall — FDA Z-2371-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Siemens Medical Solutions USA SOMATOM go.Up; Models ##11061628 Product Usage: This computed recall — FDA Z-2401-2019
The injector holder could potentially fall off together with the injector and the storage box.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded recall — FDA Z-2378-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded recall — FDA Z-2379-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Siemens Medical Solutions USA SOMATOM go.Up; Models #11061620 Product Usage: This computed recall — FDA Z-2400-2019
The injector holder could potentially fall off together with the injector and the storage box.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet recall — FDA Z-2383-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
DRG Instruments GmbH DRG Salivary Progesterone HS ELISA- IVD for the determination of recall — FDA Z-2410-2019
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a…
Class IIFDA: TerminatedDRG Instruments GmbH
Medical DeviceSep 4, 2019
Stryker GmbH Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for recall — FDA Z-2415-2019
The seal integrity of the sterile bag containing the kits may be compromised.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet recall — FDA Z-2375-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Siemens Medical Solutions USA SOMATOM go.All; Models #11061638 Product Usage: This computed recall — FDA Z-2403-2019
The injector holder could potentially fall off together with the injector and the storage box.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 4, 2019
Stryker GmbH Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed recall — FDA Z-2414-2019
The seal integrity of the sterile bag containing the kits may be compromised.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceSep 4, 2019
Stryker GmbH Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for recall — FDA Z-2413-2019
The seal integrity of the sterile bag containing the kits may be compromised.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded recall — FDA Z-2377-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product recall — FDA Z-2369-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceSep 4, 2019
Bard Peripheral Vascular GlidePath Long-Term Hemodialysis Catheter, REF/Product recall — FDA Z-2388-2019
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.