Medical DeviceMay 16, 2018
Boston Scientific Capio SLIM Suture Capturing Device, Model #M0068318250 recall — FDA Z-1616-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
27,110medical device recall records
2,329FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 851
27,110 detailed records are currently available in this category.
Medical DeviceMay 16, 2018
TP Orthodontics Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for recall — FDA Z-1795-2018
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Class IIFDA: TerminatedTP Orthodontics, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product recall — FDA Z-1550-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
PerkinElmer Life and Analytical Sciences NeoBase Succinylacetone Assay Solution, Product recall — FDA Z-1692-2018
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking…
Class IIFDA: TerminatedPerkinElmer Life and Analytical Sciences, Wallac, OY
Medical DeviceMay 16, 2018
Parker Laboratories Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model recall — FDA Z-1777-2018
There is a potential for the gel packets to have leaks in the packet seal.
Class IIFDA: TerminatedParker Laboratories, Inc.
Medical DeviceMay 16, 2018
Siemens Medical Solutions USA ACUSON SC2000 Ultrasound System recall — FDA Z-1200-2018
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 16, 2018
Boston Scientific Capio RP; Model #M0068321010. Intended for use in general suturing recall — FDA Z-1621-2018
Potential for Capio sutures to break and /or detach.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs recall — FDA Z-1552-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1734-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Datascope BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 recall — FDA Z-1723-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage recall — FDA Z-1547-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1739-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics ADVIA Centaur Folate (FOL) recall — FDA Z-1689-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Deerfield Imaging IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative recall — FDA Z-1645-2018
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the…
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1559-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Ninepoint Medical NvisionVLE Low-Profile Optical Probe recall — FDA Z-1781-2018
Distal tips of the probes may detach from the probe shaft during use.
Class IIFDA: TerminatedNinepoint Medical Inc.
Medical DeviceMay 9, 2018
Philips Medical Systems Nederlands Mutlidiagnost-Eleva with Flat Detector Eleva with Flat recall — FDA Z-1607-2018
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating…
Class IIFDA: TerminatedPhilips Medical Systems Nederlands
Medical DeviceMay 9, 2018
Southwest Technologies HYPOTHERMIA CAP Supportive in Cancer, packaged under the following recall — FDA Z-1600-2018
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of…
Class IIFDA: OngoingSouthwest Technologies Inc.
Medical DeviceMay 9, 2018
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700 recall — FDA Z-1628-2018
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Class IIFDA: TerminatedTeleflex Medical Europe Ltd
Medical DeviceMay 9, 2018
Cook StoneBreaker Exhaust Cap recall — FDA Z-1591-2018
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMay 9, 2018
Radiometer Medical ApS AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE recall — FDA Z-1582-2018
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Class IIFDA: TerminatedRadiometer Medical ApS
Medical DeviceMay 9, 2018
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers recall — FDA Z-1493-2018
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.…
Class IIFDA: OngoingBeijing Syntech Laser Co., Ltd
Medical DeviceMay 9, 2018
Philips Electronics Allura Xper R8.x.25.5 and UNIZ systems recall — FDA Z-1589-2018
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceMay 9, 2018
Roche Diagnostics cobas b 221 AutoQC Module Complete recall — FDA Z-1613-2018
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Class IIFDA: TerminatedRoche Diagnostics Corporation
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.