Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-08-08FDA-DeviceZimmer Surgical IncClass IIZimmer Dermatone AN, Model No. 88710100
Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
- 2018-08-08FDA-DeviceCovidien LLCClass IIPolysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Potential proplylene glycol contamination
- 2018-08-08FDA-DeviceEncore Medical, LpClass IIInstrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
- 2018-08-08FDA-DeviceBeckman Coulter Inc.Class IIMicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
- 2018-08-08FDA-DeviceBecton, Dickinson and Company, BD BiosciencesClass IIIBD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the corre
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
- 2018-08-08FDA-DeviceBaxter Healthcare CorporationClass IIpower cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
- 2018-08-08FDA-DeviceQIAGENClass IIEZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Underfilled reagent well that could lead to incorrect results
- 2018-08-08FDA-DeviceIntegra LifeSciences Corp.Class IIMAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- 2018-08-08FDA-DeviceIntegra LifeSciences Corp.Class IIMAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- 2018-08-08FDA-DeviceIntegra LifeSciences Corp.Class IIMAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- 2018-08-08FDA-DeviceIntegra LifeSciences Corp.Class IIMAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- 2018-08-08FDA-DeviceELITech Clinical Systems SASClass IIENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.
- 2018-08-08FDA-DeviceEnvoy Medical CorporationClass IIFinal Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
- 2018-08-08FDA-DevicebioMerieux, Inc.Class IIVIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IICT Goldseal BrightSpeed 16 PWR TIO 2 YR
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIOptima CT 540
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIOptima CT 520
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIRevolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IICT Goldseal Optima CT 600
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIRevolution CT 160 1.5D STD WAUK
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery RT labeled as: a. MID BJG; b. HVY BJG
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery MI Digital Ready
DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- 2018-08-08FDA-DeviceArrow International IncClass IIPercutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Product contains dry natural rubber latex. Label states Latex Free.
- 2018-08-08FDA-DeviceRandox Laboratories Ltd.Class IILiquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
- 2018-08-08FDA-DeviceDiamedix CorporationClass IIIDiamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Contains a gel-like contaminant that may affect product performance.
- 2018-08-08FDA-DeviceDiamedix CorporationClass IIIDiamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Contains a gel-like contaminant that may affect product performance.
- 2018-08-08FDA-DeviceLivaNova USA IncClass IIVNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
- 2018-08-08FDA-DeviceCayenne Medical Inc.Class IIDrill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
A review of complaints identified a trend for drills breaking.
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