Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIT4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- 2018-05-02FDA-DeviceDiagnostic Hybrids, Inc.Class IIIMicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
A component of the kit was found to contain bacterial contamination.
- 2018-05-02FDA-DeviceDiagnostic Hybrids, Inc.Class IIIMicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
A component of the kit was found to contain bacterial contamination.
- 2018-05-02FDA-DeviceDiagnostic Hybrids, Inc.Class IIIMicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxin
A component of the kit was found to contain bacterial contamination.
- 2018-05-02FDA-DeviceDiagnostic Hybrids, Inc.Class IIMicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HR
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
- 2018-05-02FDA-DeviceIntegra LifeSciences Corp.Class IITCC-EZ, Total Contact Cast System, Model No. TCC2-4051
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
- 2018-05-02FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
- 2018-05-02FDA-DeviceKeystone Dental IncClass IIGenesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
- 2018-05-02FDA-DeviceLife Technologies CorporationClass IIOncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
- 2018-05-02FDA-DeviceMedtronic VascularClass IIMedtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
- 2018-05-02FDA-DeviceTerumo Cardiovascular Systems CorporationClass IIFlowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
- 2018-05-02FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIM/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IISmooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIPressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIZimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIHumeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceZimmer Biomet, Inc.Class IIM/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Potential failure of sterile packaging seal.
- 2018-05-02FDA-DeviceAce Surgical Supply Co., Inc.Class IIDouble Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
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