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.
- 2021-12-15FDA-DeviceOrchestrate Orthodontic Technologies, Inc.Class IIO3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Due to product label/labeling being altered from it's approved state.
- 2021-12-15FDA-DeviceNorthgate Technologies, Inc.Class IIBoston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
- 2021-12-15FDA-DeviceCovidien LlcClass IICovidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
- 2021-12-08FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
- 2021-12-08FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
- 2021-12-08FDA-DeviceGE Healthcare, LLCClass IIGE Centricity Universal Viewer Zero Footprint Client
There is a potential to display incomplete patient imaging study.
- 2021-12-08FDA-DeviceRandox Laboratories Ltd.Class IIRANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceBoston Scientific CorporationClass IIHURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- 2021-12-08FDA-DeviceNuVasive Specialized Orthopedics, Inc.Class IINUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
- 2021-12-08FDA-DeviceMagnolia Medical Technologies, Inc.Class IIThe Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
- 2021-12-08FDA-DeviceO&M HALYARD INCClass IIHALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
- 2021-12-08FDA-DeviceWright Medical Technology IncClass IIINBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
The package contents and package labeling do not match.
- 2021-12-08FDA-DeviceWright Medical Technology IncClass IIINBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
The package contents and package labeling do not match.
- 2021-12-08FDA-DeviceHowmedica Osteonics Corp.Class II28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
There is a potential for the outer white Tyvek lid to debond from the sealed package.
- 2021-12-08FDA-DeviceHowmedica Osteonics Corp.Class II28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
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- 2021-12-08FDA-DeviceBioFire Diagnostics, LLCClass IIBioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
- 2021-12-08FDA-DeviceCardiac Assist, IncClass IIISHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
- 2021-12-08FDA-DeviceDRG International, Inc.Class IITotal Thyroxine (T4) ELISA; REF EIA-1781
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
- 2021-12-08FDA-DeviceBeeken Biomedical, LLCClass IINuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Endotoxin levels exceeded allowable limits.
- 2021-12-08FDA-DeviceThoratec Corp.Class IIAbbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
- 2021-12-08FDA-DeviceMAX LUX CORPClass IIThe product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
Excessive ultraviolet-C radiation
- 2021-12-01FDA-DeviceAtrium Medical CorporationClass IIThe Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
- 2021-12-01FDA-DeviceBecton Dickinson Infusion Therapy Systems Inc.Class IIBD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapte
There is a breach in the product packaging that renders the product non-sterile.
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