The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
113
High
287
Moderate
299
Low
51

Of the 766 recalls this month scored against our rubric, 2% are Critical, 15% are Severe.

601–700 of 766

  • 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
  • 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 (Needle-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2018·2018-03-07

    Moog Curlin Infusion Sets Recalled for Particulate Contamination

    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 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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, Edina,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0695-2018·2018-03-07

    DePuy Mitek Recalls FMS Gravity Tube Sets Due to Leakage

    DePuy Mitek is recalling FMS Gravity Tube Sets because they may leak at the bulb and tube connection during arthroscopic procedures.

    Product
    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2018·2018-03-07

    Otto Bock Kenevo Knee Joints Recalled for Pylon Breakage Risk

    Otto Bock is recalling 75 Kenevo knee joints due to a design issue that could cause the pylon to break under specific heavy-use conditions.

    Product
    OTTO BOCK Kenevo knee joints Model 3C60
    Category
    Medical Device
    Distribution
    26 states
  • 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, Goj
    Category
    Food
    Distribution
    1 state
  • 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-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 (Devices)·Z-0804-2018·2018-03-07

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

    ConMed Corporation is recalling STAT 2 I.V. Gravity Flow Controllers and administration sets because they exhibit inaccurate or inconsistent flow rates.

    Product
    STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0721-2018·2018-03-07

    Zimmer Biomet Recalls Segmental System Distal Femur Components

    Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.

    Product
    Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2018·2018-03-07

    Cook Recalls Wills-Oglesby Percutaneous Gastrostomy Sets Due to Wire Guide Defect

    Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0815-2018·2018-03-07

    Otto Bock Kenevo Knee Joints Recalled for Pylon Breakage Risk

    Otto Bock is recalling four Kenevo knee joints due to a design issue that could cause the pylon to break, leading to a fall.

    Product
    OTTO BOCK Kenevo knee joints Model 3C60=ST
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-0837-2018·2018-03-07

    M&P Food Productions Recalls Vareniki Potato and Onion for Undeclared Wheat

    M&P Food Productions is recalling Vareniki Potato and Onion because the product contains undeclared wheat. This poses a risk to individuals with wheat allergies or celiac disease.

    Product
    M&P Food Productions brand Vareniki Potato and Onion, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0 7163 02616 7
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·18V158000·2018-03-07

    Thomas Built Buses Minotour Recall for Wheelchair Lift Safety Defect

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

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2018·2018-03-07

    Avid Medical Recalls TruCustom Ortho Tray Kits Due to Foreign Material

    Avid Medical is recalling 597 TruCustom Ortho Tray kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
    Category
    Medical Device
    Distribution
    10 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 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0834-2018·2018-03-07

    M&P Food Productions Recalls Vareniki for Undeclared Wheat

    M&P Food Productions is recalling Vareniki, Potato and Mushroom, 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, Potato and Mushroom, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 07163 02617 4
    Category
    Food
    Distribution
    10 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 de
    Category
    Medical Device
    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 (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 (Devices)·Z-0737-2018·2018-03-07

    Ventana OptiView Amplification Kit Recalled for Leaking and Sticking Reagent Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0847-2018·2018-03-07

    Schmidt Baking Recalls Potato Slammers Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling Potato Slammers bread products because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    POTATO SLAMMERS ( Under the following Trade Names - SCHMIDT, WHOLE FOODS, HP, WEIS, PLAIN BAG 12 and 24 PK )
    Category
    Food
    Distribution
    8 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 (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-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 (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 (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 treatmen
    Category
    Medical Device
    Distribution
    0 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-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-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: Admini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2018·2018-03-07

    Alcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch

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

    Product
    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) 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-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 (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-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 (Food)·F-0871-2018·2018-03-07

    Meijer 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 Yogurt Blended Low-fat Blueberry 6 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 (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-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 (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 (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 (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-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 (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: Patheon
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0799-2018·2018-03-07

    Avid Medical Recalls TruCustom PV Minor Pack Convenience Kits

    Avid Medical is recalling 52 TruCustom PV Minor Pack convenience kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
    Category
    Medical Device
    Distribution
    10 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 (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-0739-2018·2018-03-07

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (Devices)·Z-0831-2018·2018-03-07

    Cook Percutaneous Gastrojejunostomy Set Recalled for Backwards Wire Guides

    Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0842-2018·2018-03-07

    Schmidt Baking Recalls Bread Products Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various white bread products sold under multiple trade names due to a potential foreign material issue in an ingredient.

    Product
    BNS WHITE ( Under the following Trade Names - Giant, Harvest Pride -Shoprite, Sunbeam, Blueribbon, Shoppers, Weis )
    Category
    Food
    Distribution
    8 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-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-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-0735-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0752-2018·2018-03-07

    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 13"x18" Heat Seal Pouch 100 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 (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 (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-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-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-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 (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 (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 (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-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 (Devices)·Z-0791-2018·2018-03-07

    Avid Medical Recalls Knee Arthroscopy Kits Due to Foreign Material

    Avid Medical is recalling 24 knee arthroscopy kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0861-2018·2018-03-07

    Schmidt Baking Recalls 8 Grain Bread Due to Potential Foreign Material

    Schmidt Baking Co. is recalling 8 Grain bread products because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    8 GRAIN ( Under the following Trade Names - INKEEPER )
    Category
    Food
    Distribution
    8 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 (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-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 lowe
    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, caroti
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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-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-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-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-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-0765-2018·2018-03-07

    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 10.5"x28" Self Seal Pouch 100 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 design
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2018·2018-03-07

    Siemens Axiom Artis Fluoroscopic Foot Switch Recalled for Potential Failure

    Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.

    Product
    Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Food)·F-0845-2018·2018-03-07

    Schmidt Baking Recalls Potato Bread Due to Potential Foreign Material

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

    Product
    P/L POTATO ( Under the following Trade Names - WHOLE FOOODS, PLAIN BAG, GIANT, HP, SHOPPERS, SHOPRITE, WEIS )
    Category
    Food
    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 (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 (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-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 (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 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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

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