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.
- 2019-07-24FDA-DevicePharmaceutical Innovations, Inc.Class IIAlpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
Potential for failed stability antimicrobial effectiveness testing.
- 2019-07-24FDA-DevicePharmaceutical Innovations, Inc.Class IIElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Potential for failed stability antimicrobial effectiveness testing.
- 2019-07-24FDA-DevicePharmaceutical Innovations, Inc.Class IIElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Potential for failed stability antimicrobial effectiveness testing.
- 2019-07-24FDA-DevicePharmaceutical Innovations, Inc.Class IIElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
Potential for failed stability antimicrobial effectiveness testing.
- 2019-07-24FDA-DevicePharmaceutical Innovations, Inc.Class IIAlpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Potential for failed stability antimicrobial effectiveness testing.
- 2019-07-24FDA-DeviceBecton Dickinson & CompanyClass IIBD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spu
The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.
- 2019-07-24FDA-DeviceDatascope CorporationClass IISensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscl
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
- 2019-07-24FDA-DeviceGE Healthcare, LLCClass IIRepair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Potential for a transducer mis-alignment in certain transvaginal probes.
- 2019-07-24FDA-DeviceGE Healthcare, LLCClass IIRefurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Potential for a transducer mis-alignment in certain transvaginal probes.
- 2019-07-24FDA-DeviceZimmer Biomet, Inc.Class IIUltra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
The products do not have sufficient data to support the labeled shelf life of 10 years.
- 2019-07-24FDA-DeviceZimmer Biomet, Inc.Class IIUltra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
The products do not have sufficient data to support the labeled shelf life of 10 years.
- 2019-07-24FDA-DeviceZimmer Biomet, Inc.Class IIComprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Lack of an adequate sterilization validation.
- 2019-07-24FDA-DeviceZimmer Biomet, Inc.Class IIComprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Lack of an adequate sterilization validation.
- 2019-07-24FDA-DeviceGE Healthcare, LLCClass IIRevolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Additional low dose radiation exposure.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
- 2019-07-24FDA-DeviceDatascope Corp.Class ICardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
- 2019-07-24FDA-DeviceTeleflex MedicalClass ITeleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotrache
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
- 2019-07-24FDA-DeviceCareFusion 303, Inc.Class IAlaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
- 2019-07-17FDA-DeviceApplied Medical Resources CorpClass IIKii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
- 2019-07-17FDA-DeviceCanon Medical System, USA, INC.Class IIRadrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image
software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
- 2019-07-17FDA-DeviceRichard Wolf Medical Instruments Corp.Class IIE-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
- 2019-07-17FDA-DeviceCOVIDIEN LLCClass IIMAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
- 2019-07-17FDA-DeviceSiemens Medical Solutions USA, IncClass IICios care fusion system
DAP chamber may be missing an insulating foil
- 2019-07-17FDA-DeviceSiemens Medical Solutions USA, IncClass IICios Alpha VA20/ VA30 mobile X-Ray systems
DAP chamber may be missing an insulating foil
- 2019-07-17FDA-DeviceRinovum Women's HealthClass IIRevive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
- 2019-07-17FDA-DeviceHelena Laboratories, Corp.Class IIColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief