Medical DeviceMay 16, 2018
Vygon U.S.A PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs recall — FDA Z-1633-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
May 2018 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceMay 16, 2018
Microline Surgical ReNew Dolphin Nose Disposable Dissector Tip recall — FDA Z-1740-2018
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Class IIFDA: TerminatedMicroline Surgical, Inc.
Medical DeviceMay 16, 2018
Straumann Emdogain 0.15 ml 5-Pack recall — FDA Z-1693-2018
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
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for recall — FDA Z-1784-2018
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, Adult, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1553-2018
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 33500 3/8" ECC PACK, Catalog No. 701053752 recall — FDA Z-1710-2018
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 Alanine Aminotransferase (ALTI) assay recall — FDA Z-1650-2018
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 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. recall — FDA Z-1733-2018
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, Infant, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1556-2018
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 M, anesthesia machine, catalog no. 8608400 Product Usage: The recall — FDA Z-1484-2018
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, Adult, with mask, oxygen reservoir bag, PEEP valve recall — FDA Z-1568-2018
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 IMMULITE ¿ /IMMULITE ¿ 1000 TG recall — FDA Z-1684-2018
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
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
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.
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.