Medical device recalls
39231 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-23FDA-DeviceTosoh Bioscience IncClass IITosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- 2018-05-23FDA-DeviceTosoh Bioscience IncClass IITosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- 2018-05-23FDA-DeviceZimmer Biomet, Inc.Class IIPersona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
- 2018-05-23FDA-DeviceZimmer Biomet, Inc.Class IIPersona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
- 2018-05-23FDA-DeviceZimmer Biomet, Inc.Class IIPersona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
- 2018-05-23FDA-DeviceZimmer Biomet, Inc.Class IIPersona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
- 2018-05-23FDA-DeviceBeckman Coulter Inc.Class IIBECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part number B1015-25 lot number 1005986140.
- 2018-05-23FDA-DeviceBard Peripheral Vascular IncClass IIBARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
- 2018-05-23FDA-DeviceBard Peripheral Vascular IncClass IIBARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
- 2018-05-23FDA-DeviceAbbottClass IThoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
- 2018-05-23FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
- 2018-05-23FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
- 2018-05-23FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
- 2018-05-23FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
- 2018-05-23FDA-DeviceMicro Therapeutics Inc, Dba Ev3 NeurovascularClass IMindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
- 2018-05-16FDA-DeviceBeaver-Visitec International Inc.Class IIWet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Products were packaged with incorrect labeling,
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIISyva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Incorrect calibrator level listed in qualitative calibration steps
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIISyva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Incorrect calibrator level listed in qualitative calibration steps
- 2018-05-16FDA-DeviceInpeco S.A.Class IIFlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
- 2018-05-16FDA-DeviceDiagnostic Hybrids, Inc.Class IIMicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
There is a possibility of low volume and/or leaking standard bottles.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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