The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
133
High
275
Moderate
293
Low
49

Of the 766 recalls this month scored against our rubric, 2% are Critical, 17% are Severe.

601–700 of 766

  • HighFDA (Devices)·Z-0700-2018·2018-03-07

    Moog Curlin Infusion Sets Recalled for Particulate Matter on Spike

    Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike. The recall covers 7,979 cases distributed nationwide and internationally.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2018·2018-03-07

    Stryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects

    Stryker Communications is recalling 850 Berchtold Chromophare Dual Monitor Carrier Arms and Flat Panels because the mounts may have missing or incomplete welds.

    Product
    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V157000·2018-03-07

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2007-2018 Thomas Built Buses Minotour school buses because the wheelchair lift may operate while the vehicle is in motion.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2018·2018-03-07

    ConMed Recalls STAT 2 I.V. Gravity Flow Sets Due to Inaccurate Flow Rates

    ConMed is recalling STAT 2 I.V. Gravity Flow Needle-Free Controller sets because they exhibit inaccurate or inconsistent flow rates.

    Product
    STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0840-2018·2018-03-07

    M&P Food Productions Vareniki Recalled for Undeclared Wheat

    M&P Food Productions is recalling Vareniki - farmer cheese due to undeclared wheat. Consumers with celiac disease or wheat allergies should not consume the product.

    Product
    M&P Food Productions brand Vareniki - farmer cheese, Hand made, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0716 302618 1
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0835-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Sour Cherry for Undeclared Allergens

    M&P Food Productions is recalling Vareniki Sour Cherry because the product contains undeclared wheat and Red #40.

    Product
    M&P Food Productions brand Vareniki Sour Cherry, Net Wt. 14oz (396g), Keep Frozen, UPC: 7 07163 02615 0
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·18V154000·2018-03-07

    BMW Recalls 2018 X3 Models for Potential Rear Spoiler Detachment

    BMW is recalling 2018 X3 xDrive30i and M40i vehicles because the rear spoiler may not be properly attached or may be missing screws, posing a road hazard.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2018·2018-03-07

    Cosmedent Etching Gel Recalled Due to Syringe Tip Detachment Risk

    Cosmedent, Inc. is recalling 84 units of Etching Gel because the syringe tips may detach during use.

    Product
    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0816-2018·2018-03-07

    Hitachi Ultrasound Transducer Recalled for Electrical Shock Hazard

    Hitachi Medical Systems America Inc is recalling 55 ultrasound transducers (Model UST-5550-R) because they may not have adequate protection against electrical shock hazards.

    Product
    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-0836-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Cabbage for Undeclared Wheat

    M&P Food Productions is recalling Vareniki Cabbage because the product contains undeclared wheat. Consumers with celiac disease or wheat allergies should not eat the product.

    Product
    M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0838-2018·2018-03-07

    M&P Food Productions Recalls Blintzes Due to Undeclared Wheat

    M&P Food Productions is recalling Hand Made Russian Style Blintzes because they contain undeclared wheat. Consumers should check their pantries for the affected product.

    Product
    M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese, Net Wt. 14 oz. (396 g); UPC Codes: 7 07163 30325 1, Keep Frozen
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0830-2018·2018-03-07

    Lunds & Byerlys White Quinoa Recalled for Undeclared Wheat Allergen

    InHarvest, Inc. is recalling Lunds & Byerlys White Quinoa because some bags contain Israeli Couscous, which includes wheat, without declaring the allergen.

    Product
    White Quinoa; 16 oz. (454g) bags with clear panel in front; UPC: 0 72431 00195 6 Brand name Lunds & Byerlys Quinoa ingredients: White Quinoa Couscous ingredients: Israeli Couscous (wheat flour, rosemary extract). Contains: Wheat. Produced for Lunds & Byerlys…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0823-2018·2018-03-07

    LifeCell Revolve Advanced Adipose System Recalled for Bacterial Endotoxins

    LifeCell is recalling 25,798 units of the Revolve Advanced Adipose System due to bacterial endotoxin levels above acceptable limits.

    Product
    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0869-2018·2018-03-07

    Margalaxy Cosmic Crunch Granola Recalled for Undeclared Coconut Flakes

    Margalaxy LLC is recalling Cosmic Crunch Granola due to undeclared coconut flakes. The product was distributed in Oregon.

    Product
    Cosmic Crunch Granola, packaged in paper bag, net wt 10 oz. The product is labeled in parts: "***COSMIC CRUNCH superfood granola***10oz***Margalaxy***Ingredients: Walnuts, Almonds, Maple Syrup, Maca Powder, Flax meal, Cinnamon, Sea Salt, Vanilla, Coconut Oil, Chia Seeds…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0701-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled for Particulate Matter

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2018·2018-03-07

    Avid Medical Recalls TruCustom Plastic Basin Kits Due to Foreign Material

    Avid Medical is recalling 440 TruCustom Plastic Basin Packs because some kits contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0708-2018·2018-03-07

    Siemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.

    Product
    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2018·2018-03-07

    Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly

    Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.

    Product
    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2018·2018-03-07

    Philips Intellivue iX Software Recall for Patient Discharge Failure

    Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.

    Product
    Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0783-2018·2018-03-07

    Avid Medical Recalls Pacemaker Tray Kits with Foreign Material

    Avid Medical is recalling 70 TruCustom Pacemaker Tray kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0832-2018·2018-03-07

    Sumano's Bakery Recalls Sourdough French Bread Due to Metal Contamination

    Sumano's Bakery is recalling Sourdough French bread after a customer found a small metal piece on the outside of the loaf before baking.

    Product
    Sourdough French: Product number 2044; SKU 61659799; GTIN [00046567600932] ; UPC 831 49000044 20 pieces; Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough). Best Practices: 1. Keep Bread frozen at all times 2. Pull bread out of freezer…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0699-2018·2018-03-07

    Moog Curlin Infusion Administration Set Recalled Due to Particulate Matter

    Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2018·2018-03-07

    Aesculap proSA Tool Set Recalled for Incorrect Valve Pressure Adjustment

    Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.

    Product
    proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0792-2018·2018-03-07

    Avid Medical Recalls TruCustom Laminectomy Kits Due to Foreign Material

    Avid Medical is recalling 12 TruCustom Laminectomy Kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0839-2018·2018-03-07

    M&P Food Productions Recalls Blintzes for Undeclared Wheat and Red Dye

    M&P Food Productions is recalling Hand Made Russian Style Blintzes because they contain undeclared wheat and FD&C Red #40.

    Product
    M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese and Cherry, Net Wt. 14 oz. (396g), UPC Codes: 7 07163 30327 5, Keep Frozen
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0722-2018·2018-03-07

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk

    Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.

    Product
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0867-2018·2018-03-07

    Kanan Enterprises Recalls Unsalted Almonds Due to Undeclared Allergens

    Kanan Enterprises is recalling Southern Grove Unsalted Almonds because some bags contained Wasabi Soy Almonds, which include undeclared wheat, soy, and peanut oil.

    Product
    SOUTHERN GROVE ALMONDS Unsalted 14 oz (397g) pouch bag INGREDIENTS: ALMONDS. Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 24647 1
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0717-2018·2018-03-07

    Philips Allura Xper FD X-ray Systems Recalled for Monitor Fall Hazard

    Philips is recalling 1,486 Allura Xper FD and ORT X-ray systems because extra monitors mounted on the ceiling suspension may disengage and fall.

    Product
    Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2018·2018-03-07

    Accord Media Recalls Truth Renew Device for Unapproved LED Light

    Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.

    Product
    Truth Renew
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2018·2018-03-07

    Steris Recalls Vis-U-All Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2018·2018-03-07

    Trumpf Medical Systems Recalls Surgical Camera Systems Due to Emission Issues

    Trumpf Medical Systems is recalling 212 surgical camera systems because their wireless receivers emit radiation above accepted limits, potentially interfering with other operating room devices.

    Product
    Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0801-2018·2018-03-07

    Avid Medical Recalls TruCustom SPINE Kits Due to Foreign Material

    Avid Medical is recalling 30 TruCustom SPINE convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0849-2018·2018-03-07

    Schmidt Baking Recalls 100% Wheat Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling 100% Wheat Hams because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    100 % WHEAT HAMS( Under the following Trade Names - OT, GAINT, GOURMET, GRAETVALUE, SHOPRITE , PLAIN BAG )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0822-2018·2018-03-07

    Accord Media Recalls Truth Renew Plus LED Light Device

    Accord Media is recalling 67 units of the Truth Renew Plus device because it uses an unapproved green LED light to treat hyperpigmentation.

    Product
    Truth Renew Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0865-2018·2018-03-07

    Schmidt Baking Recalls Potato Bread Due to Potential Foreign Material

    Schmidt Baking Co. is recalling potato bread products due to a potential foreign material issue identified by a vendor. The recall affects specific Julian code dates distributed to retail centers in eight states.

    Product
    PATATO BREAD ( Under the following Trade Names - O/T 2PK, O/T )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0874-2018·2018-03-07

    Meijer Recalls Greek Yogurt Due to Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to a precautionary measure regarding the potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Strawberry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0782-2018·2018-03-07

    Avid Medical Recalls Obstetrical Packs With Foreign Material in Needles

    Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.

    Product
    AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0793-2018·2018-03-07

    Avid Medical Recalls TruCustom Lower Extremity Kits Due to Foreign Material

    Avid Medical is recalling 120 TruCustom Lower Extremity convenience kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0854-2018·2018-03-07

    Schmidt Baking Recalls Bread Products Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various bread products sold under multiple trade names due to a potential foreign material issue identified by a vendor.

    Product
    P/L HAMS( Under the following Trade Names - CHERRY VALLEY, COMPARE, FINEFARE, GIANT, GOURMET, HP, HOLSUM, KEYFOODS, KRASDALE, METFOODS, PIONEER, REDNER, SHOPPERS, SUPERA, SUPERBREAD, TOP TOMATO, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GREAT VALUE, GENERIC, GOURMET 16CT, REDER 16CT…
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0757-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0864-2018·2018-03-07

    Schmidt Baking Recalls 100% Wheat Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling 100% Wheat bread products due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    100 % WHEAT 20 oz ( Under the following Trade Names - ALDIS, CLOVERVALLEY, GENERIC )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0706-2018·2018-03-07

    Siemens Medical Solutions Recalls Artis Q and Q.Zen Systems

    Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.

    Product
    Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2018·2018-03-07

    Avid Medical Recalls GYN Laparoscopy Kits With Foreign Material

    Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0868-2018·2018-03-07

    Bell Plantation Recalls Powdered Peanut Butter Due to E. coli Levels

    Bell Plantation Inc. is recalling 6,011 jars of Ready-to-Eat Powdered Peanut Butter because analytical results for non-pathogenic E. coli exceeded the firm's internal specifications.

    Product
    Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2018·2018-03-07

    Tosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits

    Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.

    Product
    ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-0806-2018·2018-03-07

    Baxter Recalls Mislabeled 5 mL Oral Dispensers Due to Packaging Errors

    Baxter Healthcare is recalling 2,800 units of 5 mL oral dispensers because the individual pouches are mislabeled with the wrong product code and volume.

    Product
    Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-0872-2018·2018-03-07

    Meijer Recalls Greek Yogurt Due to Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to a precautionary measure regarding the potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Plain 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0550-2018·2018-03-07

    Leadiant Recalls Subpotent Cystaran Cysteamine Ophthalmic Solution

    Leadiant Biosciences is recalling 1,705 bottles of Cystaran ophthalmic solution because the active ingredient was below the required strength.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0818-2018·2018-03-07

    Zimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors

    Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.

    Product
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0870-2018·2018-03-07

    Meijer Greek Yogurt Recalled for Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to a potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Black Cherry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0772-2018·2018-03-07

    Steris V-PRO 60 Sterilizer Software Recall to Prevent Expired Sterilant Use

    Steris Corporation is recalling 406 V-PRO 60 Low Temperature Sterilization Systems to update software that prevents the use of expired sterilant.

    Product
    V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0789-2018·2018-03-07

    Avid Medical Recalls TruCustom Kits with Foreign Material in Needles

    Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.

    Product
    AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0718-2018·2018-03-07

    Keystone Dental Recalls Max Implant System Bone Taps Due to Mislabeling

    Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.

    Product
    Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2018·2018-03-07

    Terumo Destination Guiding Sheath Recalled for Specification Deviation

    Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.

    Product
    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0704-2018·2018-03-07

    Philips ProGrade R1 Digital X-Ray Detector Recall for Image Transfer Failures

    Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.

    Product
    digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0833-2018·2018-03-07

    DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants

    DePuy Orthopaedics is recalling 23,053 DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.

    Product
    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0709-2018·2018-03-07

    Siemens Medical Solutions Recalls Wireless Foot Switches for X-Ray Systems

    Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.

    Product
    Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0834-2018·2018-03-07

    DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants

    DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.

    Product
    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0780-2018·2018-03-07

    Avid Medical Recalls TruCustom DAVINCI PACK Convenience Kits

    Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0808-2018·2018-03-07

    Siemens Syngo.via Software Recall for Diagnostic Inconsistencies

    Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.

    Product
    Syngo.via systems with SW VB20A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0720-2018·2018-03-07

    Siemens Recalls ADVIA Centaur T3 Kits Due to Barcode Scanning Issue

    Siemens is recalling ADVIA Centaur T3 kits because a barcode scanning issue on the ADVIA Centaur XPT system may affect specific lots.

    Product
    ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0863-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling specific white wheat bread products because a vendor ingredient may contain foreign material.

    Product
    WHITE WHEAT R/T ( Under the following Trade Names - O/T 2PK, O/T, WEIS, ULTRA GRAIN )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0876-2018·2018-03-07

    Divine Living Silver Recalled for Unauthorized Dietary and Health Claims

    Divine Living is recalling Silver with harmonically structured frequencies because the product contained unauthorized dietary and health claims.

    Product
    Divine Living Silver with harmonically structured frequencies A Wellness Solution 8 oz Ingredients: Structured Water, Pure Silver West Unity, Ohio 419-682-0918
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0784-2018·2018-03-07

    Avid Medical Recalls Heart Cath Tray Kits Due to Foreign Material

    Avid Medical is recalling 354 TruCustom Heart Cath Tray kits because they may contain loose polypropylene foreign material in the included needles.

    Product
    AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0856-2018·2018-03-07

    Schmidt Baking Recalls Wheat Bread Due to Potential Foreign Material

    Schmidt Baking Co. is recalling wheat bread products under various trade names due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    S/T WHEAT ( Under the following Trade Names - O/T, GIANT, HOLSUM,SHOPPERES, WEIS, GREATVALUE, O/T 2PK )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0859-2018·2018-03-07

    Schmidt Baking Recalls Whole Grain White Bread Due to Foreign Material

    Schmidt Baking Co. is recalling specific lots of Whole Grain White bread because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    WHOLE GRAIN WHITE ( Under the following Trade Names - ALDIS, BLUE RIBBON, GOURMET, SHOPRITE )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0860-2018·2018-03-07

    Schmidt Baking Recalls Honey Wheat Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling Honey Wheat bread products sold under multiple trade names due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    HONEY WHEAT ( Under the following Trade Names - ALDIS, GOURMET, GAINT, GREATVALUE, 2PK O/T, RENDERS, SUPERBREAD, SHOPRITE, WEIS )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0852-2018·2018-03-07

    Schmidt Baking Recalls Lite Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling Lite Hams sold under Gaint, ShopRite, and Weis brands due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    LITE HAMS( Under the following Trade Names - GAINT, SHOPRITE, WEIS)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0787-2018·2018-03-07

    Avid Medical Recalls TruCustom Electro Physiology Kits Due to Foreign Material

    Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0879-2018·2018-03-07

    IQ Produce Recalls Fresh Pears for Unapproved Pesticide Residue

    IQ Produce, LLC is recalling Fresh Fragrant Pears imported from China due to the presence of unapproved pesticide isocarbophos.

    Product
    Fresh Fragrant Pear; Label - Double Trees Product of China Shenzhen J.F. Fruit Co., LTD
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0844-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Sandwich Dinners Due to Foreign Material

    Schmidt Baking Co. is recalling White Wheat S/T Dinners because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    WHITE WHEAT S/T DINNERS ( Under the following Trade Names - ULTRA GRAIN, O/T )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0853-2018·2018-03-07

    Schmidt Baking Recalls Premium Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling specific lots of Premium Hams because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    PREMIUM HAMS( Under the following Trade Names - 16CT RIBBON, BLUE RIBBON SUNBEAM, ALDIS)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0873-2018·2018-03-07

    Meijer Recalls Greek Yogurt Due to Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to the potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Vanilla 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0778-2018·2018-03-07

    Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion

    Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0855-2018·2018-03-07

    Schmidt Baking Recalls Wheat Bread Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various wheat bread products due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    ALDIS S/T WHEAT BREAD ( Under the following Trade Names - ALDIS ST WHEAT, HAUSWALD, CHERRY VALLEY, COMPARE, FINEFARE, , HP, KEYFOODS, METFOODS, PIONEER,SUPERA, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GEORGES, REDER )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0761-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0545-2018·2018-03-07

    Allergan Recalls Iron Dextran Injection Due to Stability Failures

    Allergan is recalling INFeD (Iron Dextran Injection USP) because stability testing showed the product did not meet specifications for iron content.

    Product
    INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2018·2018-03-07

    Atrium Medical Recalls ProLite Mesh Due to Incorrect Configuration Packaging

    Atrium Medical is recalling 60 units of ProLite Mesh because the wrong mesh configuration was packaged in the pouch. The affected lots were distributed only to Spain.

    Product
    ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0827-2018·2018-03-07

    Siemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results

    Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.

    Product
    BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0846-2018·2018-03-07

    Schmidt Baking Recalls White Sandwich Dinners Due to Foreign Material Risk

    Schmidt Baking Co. is recalling white sandwich dinners under several brands due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    WHITE S/T DINNERS ( Under the following Trade Names - HARVEST PRIDE, HARVEST PRIDE 8 COUNT, BLUE RIBBON, GIANT, PLAIN BAG AND ROCKLAND )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0745-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2018·2018-03-07

    Teleflex Recalls Rusch Greenlite MAC 1 Tracheal Intubation Devices

    Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.

    Product
    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0788-2018·2018-03-07

    Avid Medical Recalls TruCustom Extremity Pack Kits Due to Foreign Material

    Avid Medical is recalling 48 TruCustom Extremity Pack kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0800-2018·2018-03-07

    Avid Medical Recalls Shoulder Arthroscopy Kits with Foreign Material

    Avid Medical is recalling 24 shoulder arthroscopy kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0698-2018·2018-03-07

    Moog Curlin Infusion Set Recalled for Particulate Contamination

    Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.

    Product
    MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0857-2018·2018-03-07

    Schmidt Baking Recalls Butter White Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling Butter White bread products due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    BUTTER WHITE ( Under the following Trade Names - O/T, GIANT )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0875-2018·2018-03-07

    Meijer Greek Yogurt Recalled for Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to a potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Blueberry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0781-2018·2018-03-07

    Avid Medical Recalls Vascular and Neuro Kits with Foreign Material

    Avid Medical is recalling 200 TruCustom DJ's Vascular/Neuro Tray kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0848-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling White Wheat Hams under OT, WEIS, and ULTRA GRAIN brands due to potential foreign material from a recalled ingredient.

    Product
    WHITE WHEAT HAMS( Under the following Trade Names - OT, WEIS, ULTRA GRAIN )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0866-2018·2018-03-07

    Schmidt Baking Recalls Premium White Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling various Premium White bread products because a vendor ingredient is under recall for potential foreign material.

    Product
    PREMIUM WHITE ( Under the following Trade Names - BLUERIBBON, HOLSUM 2PK, BLUERIBBON 2PK, SUNBEAM, HOLSUM, WEIS )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0743-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to enclosed devices.

    Product
    Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0759-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0841-2018·2018-03-07

    Schmidt Baking Recalls Wheat Rolls Due to Potential Foreign Material

    Schmidt Baking Co. is recalling wheat rolls sold under four trade names due to a potential foreign material issue identified by a vendor.

    Product
    BNS WHEAT ROLLS ( Under the following Trade Names - Giant, Harvest Pride, Shoppers and Old Tyme )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0843-2018·2018-03-07

    Schmidt Baking Recalls Potato Dinners Due to Foreign Material Risk

    Schmidt Baking Co. is recalling S/T Potato Dinners because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    S/T Potato Dinners ( Under the following Trade Names - SCHMIDT O/T, PLAIN BAG -ROYAL FARMS )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0546-2018·2018-03-07

    Medline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles

    Medline Industries is recalling 67,104 bottles of Povidone-Iodine Scrub Solution because the product failed to meet required iodine levels.

    Product
    POVIDONE-IODINE — POVIDONE-IODINE (POVIDONE-IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0862-2018·2018-03-07

    Schmidt Baking Recalls 12 Grain Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling 12 Grain bread products due to a potential foreign material contamination identified by a vendor.

    Product
    12 GRAIN ( Under the following Trade Names - O/T )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0821-2018·2018-03-07

    Accord Media Recalls Ultra Renew Plus LED Light Device

    Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus medical device because it uses an unapproved green LED light to treat hyperpigmentation.

    Product
    Ultra Renew Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide

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