Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-12-28FDA-DeviceAbbott Molecular, Inc.Class IIAbbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- 2022-12-28FDA-DeviceNuVasive IncClass IIX-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
- 2022-12-28FDA-DeviceHowmedica Osteonics Corp.Class IIITobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
- 2022-12-28FDA-DeviceHowmedica Osteonics Corp.Class IIIFull Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
- 2022-12-28FDA-DeviceNatus Medical IncorporatedClass IIThe Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
- 2022-12-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class II2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IIB125M Patient Monitor, REF 6160000-005-XXXXXXX
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IIB125M Patient Monitor, REF 6160000-004-XXXXXX
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IIB105M Patient Monitor, REF 6160000-003
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IIB125P Patient Monitor (with E-module slot option), REF 6160000-002
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IIB105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- 2022-12-28FDA-DeviceIcotec AgClass IIVADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
- 2022-12-28FDA-DeviceCorin LtdClass IICorin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- 2022-12-28FDA-DeviceCorin LtdClass IICorin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- 2022-12-28FDA-DeviceYoung Dental Manufacturing I, LLCClass IIIDenticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
mislabeled product
- 2022-12-28FDA-DeviceDeVilbiss Healthcare LLCClass IIDeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
- 2022-12-28FDA-DeviceConvaTec, IncClass IIConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IICentricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
- 2022-12-28FDA-DeviceGE Medical Systems, LLCClass IICentricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
- 2022-12-28FDA-DevicePHONESOAPClass IIThe product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Excessive ultraviolet-C radiation
- 2022-12-21FDA-DeviceCordis US CorpClass IICordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
There is a potential for separation at the male connector.
- 2022-12-21FDA-DeviceElekta, Inc.Class IIOncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
- 2022-12-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- 2022-12-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- 2022-12-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CATARACT PACK, REF 89-10086.05
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CATARACT PACK, REF 89-10040.01
XXX
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CATARACT PACK, REF 89-9241.04
XXX
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CATARACT PACK, REF 89-9241.03
XXX
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CATARACT PACK, REF 89-8859.08
XXX
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