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.
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 65 mm Item # 195752
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 67 mm Item # 195753
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 69 mm Item # 195754
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 71 mm Item # 195755
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 73 mm Item # 195756
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 75 mm Item # 195757
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 79 mm Item # 195758
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 83 mm Item # 195759
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 87 mm Item # 195760
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 91mm Item # 195761
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 91 mm Item # 195279
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 87 mm Item # 195278
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 83 mm Item # 195277
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 79 mm Item # 195276
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 75mm Item # 195275
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 73mm Item # 195274
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 71mm Item # 195273
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 69mm Item # 195272
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 67mm Item # 195271
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 65mm Item # 195270
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-CR Tibial Tray - Interlok 63mm Item # 195269
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP- CR Tibial Tray- Interlok 59mm Item # 195268
The locking bar not fully engaging
- 2019-09-18FDA-DeviceExactech, Inc.Class IIThreaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
- 2019-09-18FDA-DeviceAesculap Implant Systems LLCClass IICAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
possibility of the sterility batch being insufficiently sterilized
- 2019-09-18FDA-DeviceAesculap Implant Systems LLCClass IICAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
possibility of the sterility batch being insufficiently sterilized
- 2019-09-18FDA-DevicePhilips North America, LLCClass IIPhilips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
- 2019-09-18FDA-DeviceZeus Scientific, Inc.Class IIDynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.as
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
- 2019-09-18FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIMedtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
- 2019-09-18FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIMedtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
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