Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-08-28FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIN Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Iincreased (falsely elevated) Albumin results compared to expected results
- 2019-08-28FDA-DevicePro-Dex IncClass IIPRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation dr
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Enteric Viral Panel EU Catalog # 443985
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit EXT Enteric Bacterial Panel; Catalog # 443812
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Enteric Viral Panel RUO; Catalog # 443715
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Vaginal Panel; Catalog # 443712
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max GC RT PCR Assay; Catalog # 443486
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max MRSA XT; Catalog # 443461
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max StaphSR; Catalog # 443419
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max StaphSR; Catalog # 443418
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max CT/GC/TV; Catalog # 442970
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Enteric Bacterial Panel EU; Catalog # 442963
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Enteric Parasite Panel EU; Catalog # 442960
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max MRSA; Catalog # 442953
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max ExK TNA 2; Catalog # 442825
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max ExK DNA 2 EU LUO; Catalog # 442820
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max ExK DNA 2 USA; Catalog # 442819
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max ExK DNA 1 EU LUO; Catalog # 442818
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max ExK DNA 1 USA; Catalog # 442817
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Cdiff EU; Catalog # 442555
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceBecton Dickinson & Co.Class IIKit BD Max Check-Points CPO IVD EU; Catalog # 278102
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- 2019-08-28FDA-DeviceRadiometer America IncClass IIABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
- 2019-08-28FDA-DeviceQiagen Sciences LLCClass IIQIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is inten
QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
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.
- 2019-08-28FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
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.
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