Medical DeviceJun 6, 2018
Maquet SAS VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June recall — FDA Z-1937-2018
Potential keypad failure on VOLISTA StandOP Surgical Lights.
Class IIFDA: TerminatedMaquet SAS
June 2018 recalls — page 14
These records include useful source details for the selected month.
Medical DeviceJun 6, 2018
Arrow International 0.2 Micron Flat Epidural Filter recall — FDA Z-2013-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis recall — FDA Z-2032-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter recall — FDA Z-2018-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller recall — FDA Z-1957-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow PICC with Chlorag+ard Technology recall — FDA Z-2025-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM recall — FDA Z-2024-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1987-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Clear Fenestrated Drape with Adhesive recall — FDA Z-2010-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for recall — FDA Z-2031-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Echogenic Introducer Needle recall — FDA Z-1959-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1978-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-2004-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit recall — FDA Z-1992-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A recall — FDA Z-1952-2018
There is a potential for the cord to spark and cause a fire.
Class IIFDA: TerminatedGyrus Acmi, Inc.
Medical DeviceJun 6, 2018
Arrow International Arterial Catheterization Kit recall — FDA Z-1971-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International Sheath Adapter with Cath-Gard Catheter Contamination Shield for use with recall — FDA Z-2029-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Heartware Medtronic HVAD System for cardiac use recall — FDA Z-1903-2018
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that…
Class IFDA: OngoingHeartware
Medical DeviceJun 6, 2018
Siemens Healthcare Diagnostics Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 recall — FDA Z-1946-2018
Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceJun 6, 2018
Arrow International Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath recall — FDA Z-1986-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
Arrow International MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) recall — FDA Z-1983-2018
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJun 6, 2018
NordicNeuroLab AS nordicTumorEx 1.0 nordicTumorEx is an image processing software package to recall — FDA Z-2042-2018
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior…
Class IIFDA: TerminatedNordicNeuroLab AS
Medical DeviceJun 6, 2018
Torax Medical LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code recall — FDA Z-2037-2018
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Class IIFDA: TerminatedTorax Medical, Inc.
Medical DeviceJun 6, 2018
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with recall — FDA Z-1935-2018
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Class IIFDA: TerminatedMedline Industries 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.