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.
- 2020-04-29FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIFresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
- 2020-04-29FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIFresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
- 2020-04-29FDA-DeviceWilson-Cook Medical Inc.Class IIHEMO-10 Hemospray Endoscopic Hemostat
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
- 2020-04-29FDA-DeviceWilson-Cook Medical Inc.Class IIHEMO-7 Hemospray Endoscopic Hemostat
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
- 2020-04-29FDA-DeviceJohnson & Johnson Vision Care, Inc.Class IIACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Package integrity failure observed during routine shift package integrity testing at an external re-packager.
- 2020-04-29FDA-DeviceCarolina Liquid Chemistries CorpClass IIFentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
- 2020-04-29FDA-DeviceBiomerieux IncClass IIThe VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
- 2020-04-29FDA-DeviceBeckman Coulter Inc.Class IIBeckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
- 2020-04-29FDA-DeviceBoston ScientificClass IIPolaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIStretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIStretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIStretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIContour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIPercuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIPercuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IIPercuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IISensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IISensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IISensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceBoston ScientificClass IISensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-29FDA-DeviceAbbott Gmbh & Co. KGClass IIARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Precision, Model TSX-304A
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Prime SP, Model TSX-303B
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Prime, Model TSX-303A
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion One Vision, Model TSX-301C
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Premium, Model TSX-301B
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion One, Model TSX-301A
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Lightning, Model TSX-036A
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- 2020-04-22FDA-DeviceBoddingtons Plastics LtdClass IIEndocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
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