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.
- 2019-10-30FDA-DeviceSmiths Medical ASD Inc.Class IIGRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X .75" (19MM), 12/BX; 7. NDL, GRIPPER, 19G X .75" (19MM), 12/BX; 8. NDL, GRIPPER, 20G X .625" (16MM), 12/BX; 9. NDL, GRIPPER, 22G X .625" (1
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
- 2019-10-30FDA-DeviceLife Technologies Holdings Pte LtdClass IITorrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
- 2019-10-30FDA-DeviceLife Technologies Holdings Pte LtdClass IITorrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
- 2019-10-30FDA-DeviceLife Technologies Holdings Pte LtdClass IITorrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
- 2019-10-30FDA-DeviceLife Technologies Holdings Pte LtdClass IITorrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceAndover Healthcare Inc.Class IISterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
Incomplete packaging seal of sterile product
- 2019-10-30FDA-DeviceBrainlab AGClass IIPatient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
- 2019-10-30FDA-DeviceGE Healthcare, LLCClass IIApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
- 2019-10-30FDA-DeviceMedline Industries IncClass IISemi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.
Potential for the Semi-Rigid canister lid to fragment during use.
- 2019-10-30FDA-DeviceAbbott LaboratoriesClass IIEmerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
- 2019-10-30FDA-DeviceICU Medical IncClass IIPlum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
- 2019-10-30FDA-DeviceGN OtometricsClass IIThe ICS CHARTR EP 200
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
- 2019-10-30FDA-DeviceOMNIlife science Inc.Class IIOMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Stems missing porous coating on the device.
- 2019-10-30FDA-DeviceExactech, Inc.Class IIErgo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Potential for the wire to fracture at the threads and remain in the glenoid.
- 2019-10-30FDA-DeviceBaxter Healthcare CorporationClass IIEXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to
Potential ability to leak once used for compounding.
- 2019-10-30FDA-DeviceCommunity Products, LLCClass IIRifton E-Pacer, SKU K660, powered lift device
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
- 2019-10-30FDA-DeviceCommunity Products, LLCClass IIRifton TRAM Low Base, SKU K320, powered lift device
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
- 2019-10-30FDA-DeviceCommunity Products, LLCClass IIRifton TRAM Standard Base, SKU K310, powered lift device
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
- 2019-10-30FDA-DeviceDeerfield Imaging, Inc.Class IIIMRIS MR/X-ray head fixation device, Model HFD200
Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.
- 2019-10-30FDA-DeviceXintec CorpClass IIIOptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
- 2019-10-30FDA-DeviceLuminex Molecular DiagnosticsClass IIxTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
- 2019-10-30FDA-DeviceSiemens Medical Solutions USA, IncClass IIMammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
- 2019-10-23FDA-DeviceOlympus Corporation of the AmericasClass IIBerkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
- 2019-10-23FDA-DeviceVital Scientific N.V.Class IISelectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 2019-10-23FDA-DeviceVital Scientific N.V.Class IISelectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
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