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.
- 2019-10-09FDA-DevicePaltop Advanced Dental Solutions LtdClass IIPaltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
- 2019-10-09FDA-DeviceImplant Direct Sybron Manufacturing, LLCClass IIImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially a
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceInter-Med LlcClass IIVista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 2019-10-09FDA-DeviceImplant Direct Sybron Manufacturing, LLCClass IIImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
The incorrect device was packaged in the vial.
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IIExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IIExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IISECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IISECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IISECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IISECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IIStop using Metrix SECURE EVA containers
Potential for leaking product
- 2019-10-09FDA-DeviceThe Metrix CompanyClass IIStop using recalled Metrix IV containers
Potential for leaking product
- 2019-10-02FDA-DeviceMedline Industries IncClass IIMEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.
The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
- 2019-10-02FDA-DeviceAbbott Laboratories, IncClass IIAPS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
- 2019-10-02FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIAtellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA)
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure
- 2019-10-02FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Connect Diabetes Management App
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
- 2019-10-02FDA-DeviceElekta IncClass IIMonaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planni
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
- 2019-10-02FDA-DeviceElekta IncClass IIMonaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment plann
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
- 2019-10-02FDA-DeviceGETINGE US SALES LLCClass IIThe HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to colla
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
- 2019-10-02FDA-DeviceVital Scientific N.V.Class IIV-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Instrument stopped working due to a software lockup, and no patient results are produced.
- 2019-10-02FDA-DeviceRandox Laboratories Ltd.Class IIIRandox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
- 2019-10-02FDA-DeviceArrow International IncClass IIArrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
Products may contain the incorrect banner card within the kit
- 2019-10-02FDA-DeviceArrow International IncClass II8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard¿ technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate
Products may contain the incorrect banner card within the kit
- 2019-10-02FDA-DeviceSmiths Medical ASD Inc.Class IIMedfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including bl
Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion¿ 4000 pumps.
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