Medical DeviceMay 16, 2018
Boston Scientific Capio Standard Box 4 (Capio PC) recall — FDA Z-1620-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Latest records
Latest recalls — page 1435
The newest recall records with useful source details are listed here.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1554-2018
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 Cardiac Troponin I (CTNI) Flex reagent recall — FDA Z-1671-2018
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
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for recall — FDA Z-1783-2018
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, Pediatric, with mask, oxygen reservoir bag recall — FDA Z-1565-2018
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
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1737-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Boston Scientific Posterior LITE w/ Capio SLIM recall — FDA Z-1623-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Boston Scientific Uphold LITE w/ Capio SLIM recall — FDA Z-1622-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Microline Surgical ReNew Endocut Scissor Disposable Tip recall — FDA Z-1741-2018
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Class IIFDA: TerminatedMicroline Surgical, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG recall — FDA Z-1685-2018
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
Maquet Cardiopulmonary Ag CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number recall — FDA Z-1642-2018
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
Class IIFDA: TerminatedMaquet Cardiopulmonary Ag
Medical DeviceMay 16, 2018
Straumann Emdogain 0.7 ml Multipack USA recall — FDA Z-1697-2018
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
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1738-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125) recall — FDA Z-1683-2018
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
Abbott Gmbh & Co. KG ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent recall — FDA Z-1629-2018
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1573-2018
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
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for recall — FDA Z-1792-2018
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
Vygon U.S.A Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion recall — FDA Z-1634-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1736-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing recall — FDA Z-1563-2018
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 Alanine Aminotransferase (ALTI) assay recall — FDA Z-1656-2018
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
ICU Medical Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module recall — FDA Z-1775-2018
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceMay 16, 2018
Cook Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The recall — FDA Z-1751-2018
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
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1558-2018
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
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