Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-09-29FDA-DeviceIn2bones USA, LLCClass IICoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
- 2021-09-29FDA-DeviceMedtronic Perfusion SystemsClass IIDLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Potential for a wire protrusion through the left heart vent catheter tip
- 2021-09-29FDA-DeviceMedtronic Perfusion SystemsClass IIDLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Potential for a wire protrusion through the left heart vent catheter tip
- 2021-09-29FDA-DeviceGE Healthcare, LLCClass IICentricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- 2021-09-29FDA-DeviceGE Healthcare, LLCClass IICentricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- 2021-09-29FDA-DeviceArgon Medical Devices, IncClass IIScorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
- 2021-09-29FDA-DeviceSiemens Medical Solutions USA, IncClass IIComputed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur
- 2021-09-29FDA-DeviceRoche Molecular Systems, Inc.Class IIcobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Customers have reported an increased number of false positive SARS-CoV-2 results.
- 2021-09-29FDA-DeviceOlympus Corporation of the AmericasClass IIEVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
- 2021-09-29FDA-DeviceAd-Tech Medical Instrument CorporationClass IIAd-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Incorrect version of labels were used.
- 2021-09-29FDA-DeviceAd-Tech Medical Instrument CorporationClass IIAd-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Incorrect version of labels were used.
- 2021-09-29FDA-DeviceAd-Tech Medical Instrument CorporationClass IIAd-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Incorrect version of labels were used.
- 2021-09-29FDA-DeviceM.D.L. S.r.l.Class IIGeneral Manual surgical instrument
Sterility assurance may be compromised.
- 2021-09-29FDA-DeviceM.D.L. S.r.l.Class IISoft Tissue Biopsy Needles
Sterility assurance may be compromised.
- 2021-09-29FDA-DeviceM.D.L. S.r.l.Class IIMammary Nodules Localization
Sterility assurance may be compromised.
- 2021-09-29FDA-DeviceM.D.L. S.r.l.Class IIAspirated Cyto-Histological Biopsy needle
Sterility assurance may be compromised.
- 2021-09-29FDA-DeviceM.D.L. S.r.l.Class IIBone Marrow Transplantation biopsy needle
Sterility assurance may be compromised.
- 2021-09-29FDA-DeviceParagon 28, Inc.Class IIPhantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
- 2021-09-29FDA-DeviceMicrobiologics IncClass IISARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
- 2021-09-29FDA-DeviceMicrobiologics IncClass IISARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
- 2021-09-29FDA-DevicePhilips Ultrasound IncClass IIAffiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
- 2021-09-29FDA-DevicePhilips Ultrasound IncClass IIEPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
- 2021-09-29FDA-DeviceAMTEC SALES IncClass IEcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-09-29FDA-DeviceMac Medical Supply Co IncClass IUltrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-09-22FDA-DeviceWelch Allyn IncClass IIBraun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
- 2021-09-22FDA-DeviceLeica Microsystems, Inc.Class IIBOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Product may not perform as specified in IFU.
- 2021-09-22FDA-DeviceArjohuntleigh Magog, Inc.Class IIMaxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
The spreader bar can disconnect from the scale bottom attachment.
- 2021-09-22FDA-DeviceHeartware, Inc.Class IIMedtronic HVAD Pump Implant Kits
There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
- 2021-09-22FDA-DeviceQuidel CorporationClass IILyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene¿ MDx.
- 2021-09-22FDA-DevicePhilips North America LlcClass IIThe Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azuri
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
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