Medical DeviceMay 16, 2018
Boston Scientific PFR Kit- Pinnacle, Posterior recall — FDA Z-1625-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
May 2018 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceMay 16, 2018
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for recall — FDA Z-1787-2018
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Class IIFDA: TerminatedTP Orthodontics, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing recall — FDA Z-1561-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Vista Glucose (GLU) assay recall — FDA Z-1658-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm recall — FDA Z-1750-2018
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 recall — FDA Z-1686-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag recall — FDA Z-1574-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, oxygen reservoir bag recall — FDA Z-1581-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product recall — FDA Z-1666-2018
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife recall — FDA Z-1578-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
DePuy Mitek, Inc., a Johnson & Johnson Co LATARJET EXPERIENCE Sharp Curved Ostetome Product recall — FDA Z-1749-2018
Reports of product loosening or coming unscrewed from the handle.
Class IIFDA: TerminatedDePuy Mitek, Inc., a Johnson & Johnson Co.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Creatine Kinase MB (MBI) assay recall — FDA Z-1653-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics ADVIA Centaur Cyclosporine recall — FDA Z-1687-2018
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for recall — FDA Z-1785-2018
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Class IIFDA: TerminatedTP Orthodontics, Inc.
Medical DeviceMay 16, 2018
Inpeco S.A FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory recall — FDA Z-1798-2018
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid recall — FDA Z-1676-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife recall — FDA Z-1577-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Draeger Medical Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The recall — FDA Z-1483-2018
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Class IFDA: TerminatedDraeger Medical, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1555-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Vista Thyroid Stimulating Hormone (TSH) Flex recall — FDA Z-1673-2018
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Syva Emit 2000 Tacrolimus Assay recall — FDA Z-1661-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Vygon U.S.A PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the recall — FDA Z-1639-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
Medical DeviceMay 16, 2018
Straumann Emdogain 0.3 ml Multipack recall — FDA Z-1696-2018
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Class IIFDA: TerminatedStraumann Manufacturing, Inc.
Medical DeviceMay 16, 2018
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES recall — FDA Z-1641-2018
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and…
Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.