The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
228
High
281
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

701–800 of 833

  • HighFDA (Devices)·Z-0437-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0752-2018·2018-02-07

    Wegmans Garlic Parmesan Tilapia Recalled for Undeclared Soy Lecithin

    Wegmans is recalling specific packages of Ready To Cook Garlic Parmesan Tilapia because they may contain undeclared soy lecithin, a common allergen.

    Product
    Wegmans Ready To Cook Garlic Parmesan Tilapia, Single, 5 oz UPC: 2-16150-00000 and Wegmans Ready To Cook Garlic Parmesan Tilapia, Twin Pack, 15 oz UPC: 2-16154-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0501-2018·2018-02-07

    Beaver Safety Sideport Knife Recalled Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling specific batches of Beaver Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0753-2018·2018-02-07

    Wegmans Tom Tom Shrimp Recalled for Undeclared Wheat

    Wegmans is recalling Ready To Cook Tom Tom Shrimp with Sauce because the product may contain undeclared wheat.

    Product
    Wegmans Ready To Cook Tom Tom Shrimp with Sauce, 11 oz UPC: 2-06048-00000
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·18V096000·2018-02-07

    Audi Recalls S7 and RS7 Models for Incorrect Tire Weight Label

    Volkswagen Group of America is recalling 2014-2018 Audi S7 and RS7 vehicles because the tire information label lists an incorrect maximum weight, which could lead to vehicle overload.

    Product
    AUDI — AUDI S7, RS 7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0703-2018·2018-02-07

    Whole Food Market Recalls Cheesecake Bars for Undeclared Almond Flour

    Whole Food Market is recalling 20 cases of Cheesecake Bars sold in Connecticut, Massachusetts, and Rhode Island because the product may contain undeclared almond flour.

    Product
    Cheesecake Bars, PLU number 240801, 2 oz. UPC: 0240801001992
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0441-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2018·2018-02-07

    Carl Zeiss Metrotom 800 CT Scanner Recalled for Software Error

    Carl Zeiss Metrology Inc. is recalling 13 Metrotom 800 industrial CT scanners in the US and Canada due to a software error that causes the system to resume scanning automatically when the access door is closed.

    Product
    Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0413-2018·2018-02-07

    Ormco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers

    Ormco/Sybronendo is recalling 25,765 Elements Obturation Units and Buchanan Heat Pluggers because the pluggers may overheat during use.

    Product
    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0690-2018·2018-02-07

    Mary B's Southern Made Biscuits Recalled for Listeria Risk

    Hom'ade Foods is recalling Mary B's Southern Made biscuits due to potential Listeria monocytogenes contamination. Consumers should check their packages for specific dates and codes.

    Product
    Mary B's Southern Made, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Southern Made, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ) 1247g; and Mary B's Southern Made, 30 Biscuits, Family Pack, NET WT. 60 oz (3LB 12 OZ) 1701g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0485-2018·2018-02-07

    Baxter Recalls 500mL IntraVia Containers Due to Potential Sterility Leak

    Baxter Healthcare is recalling 29,088 units of 500mL IntraVia containers in the US and Canada because a leak may allow microbial contamination of the sterile fluid path.

    Product
    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0460-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0691-2018·2018-02-07

    Mary B's Tea Biscuits Recalled for Potential Listeria Contamination

    Hom'ade Foods is recalling Mary B's Tea Biscuits due to potential Listeria monocytogenes contamination. Consumers should check their packages for specific dates and codes.

    Product
    Mary B's Tea Biscuits, 24 Biscuits, Bite-Sized, NET WT. 24 oz (1LB 8 OZ) 680g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0466-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because set screws and sleeves were found out of place during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper installation.

    Product
    Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2018·2018-02-07

    Beaver Xstar Safety Slit Knives Recalled Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling 659,370 units of bvi Beaver Xstar Safety Slit Knives because the protective shield was retracted, exposing the blade.

    Product
    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0695-2018·2018-02-07

    Hom'ade Foods Recalls Mary B's Biscuits Due to Listeria Risk

    Hom'ade Foods is recalling Mary B's Made with Whole Grain Bulk Biscuits because they may be contaminated with Listeria monocytogenes.

    Product
    Mary B's Made with Whole Grain, 220CT, Bulk Biscuits
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0495-2018·2018-02-07

    Siemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues

    Siemens Medical Solutions is recalling 47 units of Syngo.plaza PACS software to fix data loss, study mix-ups, and unauthorized access risks.

    Product
    Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2018·2018-02-07

    Beaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield

    Beaver-Visitec is recalling 526,220 units of Optimum Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2018·2018-02-07

    GE Healthcare CARESCAPE Central Station software recall for communication issues

    GE Healthcare is recalling CARESCAPE Central Station software version 2.0.2 because units may experience unexpected network communication issues after boot-up or restart.

    Product
    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiologi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework error may have displaced internal components, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0644-2018·2018-02-07

    Coat & Bake Chicken Seasoning Recalled for Undeclared Milk Allergen

    Gilster-Mary Lee Corp. is recalling Coat & Bake Original Chicken seasoning because some packages contained pork seasoning with undeclared milk.

    Product
    Coat & Bake, Original Chicken, Seasoned Coating Mix For Chicken, Net Wt 5.5 OZ (156 g), Distributed by SuperValu Inc., Eden Prairie, MN.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0434-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the device from being properly assembled.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2018·2018-02-07

    C.R. Bard Recalls Uros Automated Urine Output and Temperature Monitor

    C.R. Bard is recalling two units of the Uros Automated Urine Output and Temperature Monitor in Florida due to potential measurement inaccuracies.

    Product
    BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0479-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper installation.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues

    Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2018·2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0697-2018·2018-02-07

    Ottogi Rice Cake Soup Recalled for Undeclared Milk Allergen

    Ottogi America Inc. is recalling Rice Cake Soup because it contains undeclared milk in the form of sodium caseinate.

    Product
    Ottogi Rice Cake Soup, 6.4oz. UPC 6 45175 89093 52; Item Number 29409101; Ingredients: 1. Rice Cake: Rice Water, Salt, Spirits; 2. Liquid Soup: Beef Bone Extract, Prim/starch syrup, coconut oil, sodium Caseinate, Water, Salt, Maltodextrin, Garlic, Chicken Extract Powder. (U
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0467-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2018·2018-02-07

    MicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion

    MicroAire Surgical Instruments is recalling 42 sterile twist drills because one lot contained an incorrect 2.0mm drill alongside the correct 1.6mm drill.

    Product
    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0454-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0758-2018·2018-02-07

    Clover Valley Iced Oatmeal Cookies Recalled for Undeclared Allergens

    Dollar General is recalling Clover Valley Iced Oatmeal Cookies because they are actually Coconut Macaroon Cookies containing undeclared milk and tree nuts.

    Product
    Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CONTAINS: WHEAT, SOY. DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 UPC 0 86106 03201 5
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-0476-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2018·2018-02-07

    Glenmark Mometasone Furoate Cream Recalled for Gritty Texture

    Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream due to market complaints about a gritty texture.

    Product
    Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0475-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2018·2018-02-07

    Exactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components

    Exactech is recalling 30 Equinoxe Cage, Glenoid, Alpha, Small components due to potential mislabeling. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the pr
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0315-2018·2018-02-07

    Medline Incision Drainage Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling specific lots of Incision Drainage Trays because the iodine concentration is below the label claim.

    Product
    Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0418-2018·2018-02-07

    Alere Triage Drugs of Abuse Plus TCA 25 Test Kit Recalled for False Positives

    Alere San Diego, Inc. is recalling specific lots of the Triage Drugs of Abuse Plus TCA 25 Test Kit because they produced unexpected false positive THC results.

    Product
    Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2018·2018-02-07

    Roche Elecsys 2010 Analyzer Software Malfunction Recall

    Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.

    Product
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Catheter Insertion Trays

    Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0341-2018·2018-02-07

    PD-Rx Recalls Ibuprofen 200 mg Tablets Due to Manufacturing Deviations

    PD-Rx Pharmaceuticals is voluntarily recalling 7,174 bottles of Ibuprofen 200 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0252-2018·2018-02-07

    Medline Recalls Povidone-Iodine Prep Pads Due to Low Iodine Content

    Medline Industries is recalling Aplicare Povidone-Iodine Prep Pads because the iodine content is below the labeled claim.

    Product
    Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0269-2018·2018-02-07

    Medline Sheath Removal Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.

    Product
    Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2018·2018-02-07

    Edwards HemoSphere System Recalled for Pre-Procedural Software Defects

    Edwards Lifesciences is recalling 198 HemoSphere System devices due to pre-procedural software defects. The devices are distributed in 11 US states.

    Product
    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0699-2018·2018-02-07

    Mom's Delicious Kitchen Recalls Kvas Due to Compromised Package Integrity

    Mom's Delicious Kitchen LLC is recalling gallon jugs of Kvas because holes were punched in the lids, compromising package integrity.

    Product
    Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingredients: Water, Cane Sugar, Instant Coffee, Yeast, Apple Cider***Home made to your taste with Low Calories! Keep Refrigerated to Prevent from pe
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0243-2018·2018-02-07

    Neutrogena Acne Proofing Cleanser Recalled for Container Leakage

    Johnson & Johnson is recalling Neutrogena Acne Proofing whipped foam cleanser because the containers may leak propellant and product.

    Product
    Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2018·2018-02-07

    Medline Skin Biopsy Pack Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Skin Biopsy Packs because the iodine concentration is below the label claim.

    Product
    Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0421-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0457-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2018·2018-02-07

    Neutrogena Holiday Trays Recalled for Container Leakage

    Johnson & Johnson is recalling Neutrogena Elevated 4-Holiday Trays due to defective containers that leak propellant and product.

    Product
    Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0246-2018·2018-02-07

    JCB Laboratories Recalls Subpotent Cefuroxime Ophthalmic Injection Syringes

    JCB Laboratories is recalling 6,510 syringes of Cefuroxime Ophthalmic Solution for Injection because the product is subpotent prior to its expiration date.

    Product
    Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0284-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0244-2018·2018-02-07

    Neutrogena Whipped Foam Cleanser Recalled for Container Leakage

    Johnson & Johnson is recalling specific lots of Neutrogena deep clean purifying whipped foam cleanser because the containers may leak propellant and product.

    Product
    Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0249-2018·2018-02-07

    Taro Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure

    Taro Pharmaceuticals is recalling 27,792 tubes of Clobetasol Propionate Cream 0.05% because the product failed content uniformity specifications.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0492-2018·2018-02-07

    Tosoh AIA-900 Sorters Recalled for Potential Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0415-2018·2018-02-07

    Exactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling

    Exactech is recalling 30 Equinoxe shoulder implants because they may be mislabeled. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.

    Product
    Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the p
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0442-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0473-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0305-2018·2018-02-07

    Medline Incision Drainage Kit Recalled for Subpotent Iodine Content

    Medline is recalling Incision Drainage Kits because the iodine content is below the labeled claim. The product was distributed nationwide and internationally.

    Product
    Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0682-2018·2018-02-07

    Jarrow Formulas Liquid L-Carnitine Recalled Due to Microbial Testing Results

    Jarrow Formulas is recalling one lot of Liquid L-Carnitine because a higher-than-normal micro result was found during testing.

    Product
    Jarrow Formulas Liquid L-Carnitine; 16 fl oz. (475 ml) bottle, dietary supplement; product number 102006; UPC 7 90011 02006 6; Vitamin B5 10 mg; L-Carnitine 1000 mg; Other ingredients: Purified water, xylitol, glycerin, citric acid, natural lemon-lime flavor, nisin (as a p
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2018·2018-02-07

    Tosoh AIA-900 Analyzer Recalled for Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2018·2018-02-07

    Medline Newborn Kit Recalled for Subpotent Povidone-Iodine Prep Pads

    Medline Industries is recalling 288 cases of Newborn Kits because the Povidone-Iodine prep pads contain subpotent iodine, falling below the 0.85% label claim.

    Product
    Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0497-2018·2018-02-07

    Smiths Medical Recalls Graseby 3300 Pumps Due to Key Mismatch

    Smiths Medical is recalling 77 Graseby 3300 syringe pumps and accessories because the supplied lock and key may not match the standard key.

    Product
    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0264-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide

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