Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max CT/GC/TV recall — FDA Z-2331-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
August 2019 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA MAGNETOM Skyra magnetic resonance diagnostic devices Model # recall — FDA Z-2343-2019
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX recall — FDA Z-2350-2019
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA ACUSON NX3 Elite Diagnostic Ultrasound System, Model # recall — FDA Z-2353-2019
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 68 I.U recall — FDA Z-2309-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max StaphSR recall — FDA Z-2333-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA MAGNETOM Prisma magnetic resonance diagnostic devices Model recall — FDA Z-2345-2019
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in recall — FDA Z-2292-2019
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for…
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max ExK DNA 2 EU LUO recall — FDA Z-2326-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max Vaginal Panel recall — FDA Z-2336-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX recall — FDA Z-2352-2019
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max MRSA; Catalog # 442953 recall — FDA Z-2328-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch recall — FDA Z-2340-2019
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Class IIFDA: TerminatedPro-Dex Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max ExK DNA 1 EU LUO recall — FDA Z-2324-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System recall — FDA Z-2225-2019
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max ExK TNA 2 recall — FDA Z-2327-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood recall — FDA Z-2303-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA MAGNETOM Spectra magnetic resonance diagnostic devices Model # recall — FDA Z-2344-2019
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood recall — FDA Z-2307-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max Enteric Viral Panel EU Catalog # 443985 recall — FDA Z-2339-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Siemens Medical Solutions USA ACUSON NX2 Elite Diagnostic Ultrasound System, Model # recall — FDA Z-2351-2019
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection recall — FDA Z-2297-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 34 I.U recall — FDA Z-2308-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Arcos Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125 recall — FDA Z-2295-2019
Battery packs may heat up abnormally and ignite in rare instance.
Class IIFDA: TerminatedArcos, 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.