Medical DeviceMay 16, 2018
Vygon U.S.A Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the recall — FDA Z-1636-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
May 2018 recalls — page 13
These records include useful source details for the selected month.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1576-2018
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
Datascope BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 recall — FDA Z-1726-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for recall — FDA Z-1791-2018
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
Michigan Instruments Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 recall — FDA Z-1632-2018
A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the…
Class IIIFDA: TerminatedMichigan Instruments, Inc.
Medical DeviceMay 16, 2018
Cook Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The recall — FDA Z-1754-2018
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMay 16, 2018
Datascope BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 recall — FDA Z-1730-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Siemens Medical Solutions USA Syngo.plaza software Syngo.Plaza is a Picture Archiving and recall — FDA Z-1700-2018
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 16, 2018
Tornier AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral recall — FDA Z-1757-2018
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Class IIFDA: TerminatedTornier, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer recall — FDA Z-1575-2018
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, 28inch large bore tubing recall — FDA Z-1564-2018
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
Datascope BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 recall — FDA Z-1713-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Vista Mass Creatine Kinase (MMB) Flex reagent recall — FDA Z-1672-2018
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
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product recall — FDA Z-1663-2018
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
Draeger Medical Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage recall — FDA Z-1482-2018
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
Synthes (USA) Products Retractor f/Sciatic Nerve Long recall — FDA Z-1759-2018
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceMay 16, 2018
Diagnostic Hybrids MicroVue BAP EIA, Model 8012, provides a quantitative measure of recall — FDA Z-1797-2018
There is a possibility of low volume and/or leaking standard bottles.
Class IIFDA: TerminatedDiagnostic Hybrids, Inc.
Medical DeviceMay 16, 2018
Datascope NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 recall — FDA Z-1725-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer recall — FDA Z-1570-2018
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
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167 recall — FDA Z-1643-2018
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Ammonia (AMM) assay recall — FDA Z-1649-2018
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
Vyaire Medical AirLife Resuscitation, Replacement kit for outer shell, Broselow Product recall — FDA Z-1579-2018
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 Glucose (GLUC) assay recall — FDA Z-1652-2018
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
Datascope BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. recall — FDA Z-1717-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
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.