Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-04-21FDA-DeviceKrishe IncClass IIDasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
- 2021-04-21FDA-DeviceKrishe IncClass IIDisposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
- 2021-04-21FDA-DeviceCovidien LlcClass IICovidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
- 2021-04-21FDA-DeviceVectornate USA IncClass IIMedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
- 2021-04-21FDA-DeviceBecton Dickinson & Co.Class IIBioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
- 2021-04-21FDA-DeviceEOS ImagingClass IIThe EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics)
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
- 2021-04-21FDA-DeviceRoche Molecular Systems, Inc.Class IIcobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
- 2021-04-21FDA-DeviceRoche Molecular Systems, Inc.Class IIcobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
- 2021-04-21FDA-DeviceFujifilm Medical Systems U.S.A., Inc.Class II¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
- 2021-04-21FDA-DeviceCovidienClass IICovidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
- 2021-04-21FDA-DeviceK2M, IncClass IIChesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
- 2021-04-21FDA-DeviceOriGen Biomedical, Inc.Class IIIEvolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
- 2021-04-21FDA-DeviceBiomerieux IncClass IIVIDAS¿ CMV IgM 30 Tests
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
- 2021-04-21FDA-DeviceMedline Industries IncClass IIDiluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Possible false negative or false positive results due to the product being compromised during shipment.
- 2021-04-21FDA-DeviceCentinel Spine, Inc.Class IIProdisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- 2021-04-21FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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