The Recall Desk

Archive

May 2020 recalls

456 recalls were announced in May 2020.

What the numbers show

Critical
3
Severe
100
High
239
Moderate
97
Low
17

Of the 456 recalls this month scored against our rubric, 1% are Critical, 22% are Severe.

Which agencies issued them

301–400 of 456

  • HighFDA (Food)·F-0935-2020·2020-05-13

    La Sonorense Wheat Flour Tortillas Recalled for Undeclared Wheat

    La Sonorense, Inc. is recalling hand-stretched wheat flour tortillas because the product does not properly display the list of ingredients and contains undeclared wheat.

    Product
    16", 14", 13", 12", 10", 5" Hand Stretched Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1891-2020·2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform 60 Reloads Due to Staple Deployment Issues

    Intuitive Surgical is recalling specific daVinci XI Sureform 60 Reloads because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.

    Product
    REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1861-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V272000·2020-05-13

    Audi Recalls 2020 Q8 Models for Transmission Fluid Leak Risk

    Volkswagen is recalling 2020 Audi Q8 vehicles because a defective transmission oil pipe may leak fluid, making roads slippery and increasing crash risk.

    Product
    AUDI — AUDI Q8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2020·2020-05-13

    NuVasive MAGEC 2 Spinal Rods Recalled for Actuator Separation

    NuVasive Inc. is recalling MAGEC 2 spinal rods because actuator end caps may separate, exposing internal components and releasing titanium wear debris.

    Product
    NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1902-2020·2020-05-13

    Delfi VariFit Sterile Thigh Tourniquet Cuffs Recalled for Weld Defect

    Delfi Medical Innovations is recalling certain lots of VariFit Sterile Single Use Thigh Cuffs due to a potential weld defect that may cause the cuff to leak.

    Product
    DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1862-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Line Holes

    Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2020·2020-05-13

    CME America Recalls BodyGuard Microset Infusion Sets Due to Filter Defect

    CME America is recalling BodyGuard Microset infusion sets because the installed filter may have the incorrect pore size. The recall affects 30,300 units distributed nationwide.

    Product
    BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2020·2020-05-13

    Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V269000·2020-05-13

    2020–2021 Forest River Vibe Trailers Recalled for Missing Refrigerator Roof Vent

    Forest River is recalling certain 2020–2021 Vibe trailers because the roof vent for the refrigerator may be missing. Without proper ventilation, the refrigerator could overheat and create a fire risk, or carbon monoxide could accumulate inside the trailer.

    Product
    FOREST RIVER — FOREST RIVER VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Packaged in Unsealed Pouches

    Stryker is recalling 21,078 units of Spy-Phi Drapes because they were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2020·2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect

    Intuitive Surgical is recalling 22,752 daVinci XI Sureform 60 reloads worldwide because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·010-2020·2020-05-13

    Evans Food Group Recalls Pork Skin Products Due to Undeclared Soy

    Evans Food Group is recalling ready-to-eat pork skin products because the variety pack label fails to declare soy, a known allergen.

    Product
    Evans Food Group — Evans Food Group Recalls Ready-To-Eat Pork Skin Products due to Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2020·2020-05-13

    Siemens AXIOM Aristos FX X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 314 AXIOM Aristos FX x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1879-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2020·2020-05-13

    Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure

    Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.

    Product
    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process. The recall covers lots Y47472 and Z000V0 distributed nationwide.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2020·2020-05-13

    Inpeco Centrifuge Module Recall for Potential Unbalanced Load Damage

    Inpeco S.A. is recalling 23 Abbott Accelerator a3600 Centrifuge Modules because a loading algorithm defect may cause unbalanced loads that could damage the equipment.

    Product
    Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1864-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 25 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1919-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1923-2020·2020-05-13

    Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue

    Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.

    Product
    Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1905-2020·2020-05-13

    Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets

    Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.

    Product
    Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1903-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Due to Manufacturing Defect

    Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1906-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci SP Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.

    Product
    da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0936-2020·2020-05-13

    La Sonorense Recalls Whole Wheat Flour Tortillas for Undeclared Wheat

    La Sonorense, Inc. is recalling whole wheat flour tortillas because the packaging does not properly display the ingredient list and contains undeclared wheat.

    Product
    14", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0934-2020·2020-05-13

    La Sonorense Pressed Wheat Flour Tortillas Recalled for Undeclared Wheat

    La Sonorense, Inc. is recalling pressed wheat flour tortillas because the product does not properly display the list of ingredients and contains undeclared wheat.

    Product
    12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1259-2020·2020-05-13

    Sandoz Recalls Infuvite Pediatric Injection Due to Defective Container Crimping

    Sandoz is recalling 17,500 units of Infuvite Pediatric Multiple Vitamins Injection due to sub-optimal crimping in the vial. The product was distributed nationwide.

    Product
    INFUVITE PEDIATRIC — INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Components Due to Manufacturing Defect

    Ortho Development Corporation is recalling 29 tibial tray components due to a manufacturing defect that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1856-2020·2020-05-13

    Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws

    Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.

    Product
    Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1857-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.

    Product
    Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages may contain incorrect screws that could loosen.

    Product
    Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2020·2020-05-13

    ICU Medical Recalls Cogent Hemodynamic Monitoring System Due to Software Defect

    ICU Medical is recalling 123 units of the Cogent Hemodynamic Monitoring System because a software issue prevents the system from storing patient IDs and information.

    Product
    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1892-2020·2020-05-13

    Trilliant Surgical Recalls 3.5mm Aresenal Screw Drill Bits Due to Labeling Error

    Trilliant Surgical, LLC is recalling 3.5mm Aresenal Screw Drill Bits due to a labeling error where the lot number is incorrectly marked, potentially impacting device traceability.

    Product
    3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2020·2020-05-13

    TeDan Recalls Fukushima Suction Tubes Due to Incorrect Raw Material

    TeDan Surgical Innovations LLC is recalling Fukushima suction tubes because incorrect raw material was used in production. The affected units were distributed in New Jersey.

    Product
    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2020·2020-05-13

    Inpeco FlexLab Centrifuge Module Recalled for Potential Load Imbalance

    Inpeco S.A. is recalling 65 FlexLab Centrifuge Modules because a tube loading algorithm defect may cause unbalanced loads that could damage the equipment.

    Product
    Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1851-2020·2020-05-13

    Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling

    Nobel Biocare is recalling 228 dental implants because the packaging label incorrectly lists the length as 7mm instead of the actual 10mm.

    Product
    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1910-2020·2020-05-13

    Gentell Honey Hydrogel Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling Gentell Honey Hydrogel because the product was not properly registered with the FDA, as discovered during an audit.

    Product
    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw that could loosen.

    Product
    Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1889-2020·2020-05-13

    Inpeco Siemens Aptio Centrifuge Module Recall for Tube Loading Algorithm Defect

    Inpeco S.A. is recalling 313 Siemens Aptio Automation Centrifuge Modules because a tube loading algorithm may cause unbalanced loads that could damage the centrifuge.

    Product
    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1922-2020·2020-05-13

    Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue

    Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.

    Product
    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1260-2020·2020-05-13

    Teva Recalls Epinephrine Auto-Injectors Due to CGMP Deviations

    Teva Pharmaceuticals is recalling Epinephrine Injection USP auto-injectors due to out-of-specification trigger force. The product was not distributed to the public.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1850-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date Labeling

    Epimed International is recalling 701 units of R-F Injector Cannulas due to incorrect expiration dates on the packaging. The devices were distributed worldwide and across multiple US states.

    Product
    R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2020·2020-05-13

    Nobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 227 Esthetic Abutment CC RP 1.5 mm units because they may contain incorrect screws that could loosen.

    Product
    Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2020·2020-05-13

    Northgate Technologies Recalls 9 FR AUTOLITH Probes for Biocompatibility Testing Failure

    Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.

    Product
    Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2020·2020-05-13

    R82 A/S Recalls Chest Supports for Loose Plastic Plug

    R82 A/S is recalling 2,230 chest supports for the R82 Mustang and Rabbit Up because a plastic plug can come loose without tools.

    Product
    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1924-2020·2020-05-13

    Wright Medical Recalls Inbone Tibial Trays Missing Plasma Coating

    Wright Medical Technology Inc is recalling 22 units of Inbone Tibial Trays because one lot is missing the required plasma coating.

    Product
    WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1894-2020·2020-05-13

    Abbott Recalls C Peptide Calibrators Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrators distributed in Mexico due to an error in the renewal documentation process for the local license.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1893-2020·2020-05-13

    Abbott Recalls Architect C Peptide Reagents Due to Licensing Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1908-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1909-2020·2020-05-13

    Gentell Honey Hydrogel Saturated Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 4,348 units of Gentell Honey Hydrogel Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1907-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 85,586 units of Gentell Honey Hydrogel 2"x2" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1849-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

    Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

    Product
    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1895-2020·2020-05-13

    Abbott Recalls C Peptide Calibrator Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrator in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • SevereUSDA FSIS·009-2020·2020-05-12

    Ideal Foods Recalls Flatbread Pizzas Produced Without Federal Inspection

    Ideal Foods is recalling approximately 3,302 pounds of meat and poultry flatbread pizzas produced without federal inspection. No adverse reactions have been reported.

    Product
    Ideal Foods — Ideal Foods Recalls Meat and Poultry Flatbread Pizza Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·PHA-05122020-01·2020-05-12

    P&S Raw Beef Ravioli Alerted for Possible E. Coli O157:H7 Contamination

    USDA FSIS issued a public health alert for P&S raw beef ravioli due to possible E. coli O157:H7 contamination. Consumers should discard or return the product.

    Product
    P&S Ravioli — FSIS Issues Public Health Alert for Raw Beef Ravioli Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·20V266000·2020-05-12

    Blue Bird Recalls School Buses Due to Air Conditioner Fire Risk

    Blue Bird is recalling 2020-2021 Vision and All American school buses because an incorrectly installed air conditioning circuit breaker may increase the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V267000·2020-05-12

    Blue Bird Recalls 2020-2021 Transit Buses for A/C Fire Risk

    Blue Bird is recalling 2020-2021 Vision and All American buses because an incorrectly installed air conditioning circuit breaker may increase the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V258000·2020-05-08

    Blue Bird Recalls 2020-2021 School Buses for Parking Brake Assembly Defect

    Blue Bird is recalling 2020-2021 Vision and All American school buses because the foot pedal parking brake assembly may be improperly assembled, potentially failing to hold the vehicle on an incline.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V261000·2020-05-08

    Maintainer Recalls 2019-2020 International and Chevrolet Tow Vehicles for PTO Defect

    Maintainer is recalling 16 modified 2019-2020 International CV and Chevrolet Silverado tow vehicles because incorrectly installed Power Take Offs may loosen, risking transmission fluid loss and rear wheel lockup.

    Product
    INTERNATIONAL MOTORS — INTERNATIONAL MOTORS, INTERNATIONAL CHEVY SILVERADO MEDIUM DUTY, CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V259000·2020-05-08

    Blue Bird Recalls 2020-2021 Vision and All American Transit Buses

    Blue Bird is recalling 2020-2021 Vision and 2021 All American buses because the parking brake may fail to hold the vehicle on an incline.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V262000·2020-05-08

    Ford Recalls 2020 Expedition and Navigator for Pre-Collision Assist Defect

    Ford is recalling 2020 Expedition and Lincoln Navigator vehicles because the Pre-Collision Assist feature is not enabled due to incorrect coding, increasing crash risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V263000·2020-05-08

    Ford Recalls 2019-2020 Mustang and 2019 Expedition for Warning Defect

    Ford is recalling 2019-2020 Mustang and 2019 Expedition vehicles because the 'Transmission Not In Park' warning is shorter than intended, which may increase the risk of unintended vehicle movement.

    Product
    FORD — FORD MUSTANG, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E030000·2020-05-08

    McNeilus Recalls CNG Fuel Systems with Defective Pressure Relief Devices

    McNeilus is recalling certain CNG fuel systems sold as aftermarket parts because the pressure relief devices may fail to vent during heat exposure, potentially causing the system to rupture.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:PRESSURE RELIEF DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V255000·2020-05-07

    Navistar Recalls 2018-2020 International Trucks Due to Engine Defect

    Navistar is recalling 2018-2020 International LT and 2019-2020 RH trucks because a wrist pin bushing failure may cause unexpected engine shutdown and increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT, RH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V254000·2020-05-07

    GM Recalls 2015-2016 Chevrolet SS and Caprice for Steering Defect

    General Motors is recalling 2,281 vehicles due to potential loss of electric power steering assist caused by connector corrosion.

    Product
    CHEVROLET — CHEVROLET CHEVEROLET SS, CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20741·2020-05-07

    Sobeauty Recalls Mag Cube Magnetic Ball Sets Due to Ingestion Risk

    Sobeauty is recalling Mag Cube magnetic ball sets because the small, high-powered magnets pose a serious risk of intestinal injury or death if swallowed by children.

    Product
    Mag Cube magnetic ball sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20119·2020-05-07

    Noah Clothing Recalls Men's Reverse Fleece Hoodies for Burn Hazard

    Noah Clothing is recalling men's reverse fleece hoodies because they fail federal flammability standards, posing a burn risk. No injuries have been reported.

    Product
    Noah Reverse Fleece Hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20118·2020-05-07

    Poppin' Cobs Microwave Popcorn Recalled for Fire and Burn Hazards

    Fully Popped is recalling Poppin' Cobs 10 Pack Microwave Popcorn because the paper bags can catch fire in the microwave, posing fire and burn hazards.

    Product
    Poppin' Cobs 10 Pack Microwave Popcorn
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2020·2020-05-06

    Whole Foods Market Recalls Minestrone Soup for Undeclared Milk

    Whole Foods Market is recalling Minestrone Soup sold in deli containers and bags because it may contain undeclared milk.

    Product
    Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning with 248529 for soup sold in clear plastic deli-style containers of various weight and 246691 for soup sold in clear plastic bags weighing 7 lbs. 12 oz.
    Category
    Food
    Distribution
    33 states
  • SevereFDA (Devices)·Z-1806-2020·2020-05-06

    Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure

    Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.

    Product
    Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1747-2020·2020-05-06

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.

    Product
    Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0928-2020·2020-05-06

    Frozen Flounder Stuffed with Seafood Recalled for Undeclared Allergens

    Freedman Food Service is recalling frozen flounder stuffed with seafood due to undeclared wheat, soy, eggs, and milk.

    Product
    7126763 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 3.00 (1.36 KG), 4 packages per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1836-2020·2020-05-06

    Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

    Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.

    Product
    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1257-2020·2020-05-06

    B. Braun Recalls Ceftazidime and Dextrose Injection Due to Stability Failures

    B. Braun Medical Inc. is recalling one lot of Ceftazidime for Injection USP and Dextrose for Injection USP because the product failed stability specifications for high molecular weight polymers.

    Product
    Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0924-2020·2020-05-06

    Homestead Creamery Unsalted Butter Recalled for Listeria Risk

    Homestead Creamery is recalling unsalted butter due to potential Listeria monocytogenes contamination. The product was distributed in the mid-Atlantic and northeast regions.

    Product
    Homestead Creamery Unsalted Butter. 0.45 lb. net weight. 1 unit per package, cellophane wrap
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2020·2020-05-06

    Welch Allyn X12+ Telemeter and Patient Cable Recall for Defibrillation Safety

    Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.

    Product
    X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2020·2020-05-06

    Philips Azurion 7 M20 XperGuide Software Recall for Incorrect Overlay Display

    Philips is recalling Azurion 7 M20 systems with XperGuide software because a software defect may display incorrect needle paths if the L-arm is mispositioned.

    Product
    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0922-2020·2020-05-06

    Tops Mint Dark Chocolate Bars Recalled for Undeclared Milk

    Tops Markets is recalling Mint Flavor Pure Dark Chocolate bars because they contain undeclared milk, a major allergen.

    Product
    Tops Mint Flavor Pure Dark Chocolate 45% Cocoa NET WT 3.5 oz.(100g)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1821-2020·2020-05-06

    Alcon Air Optix Night & Day Aqua Contact Lenses Recalled for Counterfeit Concerns

    Allied Vision Group is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because potentially counterfeit products and packaging were imported to the U.S.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2020·2020-05-06

    Stryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling

    Stryker Sustainability Solutions is recalling 90 reprocessed Zimmer tourniquet cuffs because they are potentially mislabeled. The mislabeling could lead to device misuse or inadequate limb compression during surgery.

    Product
    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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