The Recall Desk

Archive

March 2017 recalls

854 recalls were announced in March 2017.

What the numbers show

Critical
90
Severe
216
High
382
Moderate
134
Low
32

Of the 854 recalls this month scored against our rubric, 11% are Critical, 25% are Severe.

401–500 of 854

  • SevereUSDA FSIS·026-2017·2017-03-16

    Flagship Food Group Recalls Frozen Burritos Due to Plastic Contamination

    Flagship Food Group is recalling approximately 8,622 pounds of frozen breakfast burritos sold at Trader Joe's in Illinois and Pennsylvania due to possible hard clear plastic contamination.

    Product
    Flagship Food Group — Flagship Food Group Recalls Frozen Burrito Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·17V179000·2017-03-16

    2016 Smart Fortwo Recalled for Headlight Adjustment Seal Defect

    Mercedes-Benz USA is recalling 2016 Smart Fortwo vehicles because the headlight adjustment mechanism may not be properly sealed, potentially allowing improper horizontal adjustment.

    Product
    SMART — SMART FORTWO COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1257-2017·2017-03-15

    Physio-Control Recalls LIFEPAK 1000 Defibrillators for Unexpected Power-Offs

    Physio-Control is recalling 133,330 LIFEPAK 1000 defibrillators worldwide because they may unexpectedly power off during use.

    Product
    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1433-2017·2017-03-15

    Siemens Medical Recalls 35 MEVATRON M 6700 Linear Accelerators

    Siemens Medical Solutions USA is recalling 35 MEVATRON M 6700 linear accelerators due to a defective weld seam that could cause the overhead suspension to fall and injure a patient or other person.

    Product
    MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1585-2017·2017-03-15

    Versa Marketing Recalls Fusia Szechuan Stir Fry Due to Listeria

    Versa Marketing is recalling Fusia Asian Aspirations Szechuan Stir Fry because the product tested positive for Listeria monocytogenes. The recall affects 4,089 cases sold at Aldi stores nationwide.

    Product
    Fusia Asian Aspirations Szechuan Stir Fry; A delicious blend of premium vegetables with a savory sauce packed in a plastic bag: Sauce packet included. NET WT 21 oz. (1 lb 5 oz) 595 g
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2017·2017-03-15

    Siemens MEVATRON KD-2 Linear Accelerators Recalled for Defective Weld Seams

    Siemens is recalling 35 MEVATRON KD-2 linear accelerators due to defective weld seams that could break and cause the overhead suspension to fall, posing a risk of severe injury.

    Product
    MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2017·2017-03-15

    RBR Meat Company Recalls Frozen Supreme Pizza Due to Listeria Risk

    RBR Meat Company is recalling approximately 21,220 pounds of frozen Marketside Extra Large Supreme Pizza due to possible Listeria monocytogenes contamination.

    Product
    RBR Meat Co., Inc. — RBR Meat Company, Inc. Recalls Frozen Pizza Product Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1435-2017·2017-03-15

    Siemens MEVATRON M 7400/7440 Linear Accelerators Recalled for Defective Welds

    Siemens is recalling 35 MEVATRON M 7400/7440 linear accelerators because a defective weld seam could break, causing the overhead suspension to fall and potentially injure patients or others.

    Product
    MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1428-2017·2017-03-15

    Villa Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Apollo multi-function x-ray systems because the footrest detached from the table, causing a patient to fall.

    Product
    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1432-2017·2017-03-15

    Siemens PRIMUS HI and Mevatron M2 Linear Accelerators Recalled for Weld Defect

    Siemens is recalling 35 PRIMUS HI and Mevatron M2 linear accelerators due to a defective weld seam that could cause overhead suspensions to fall and injure people.

    Product
    PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1430-2017·2017-03-15

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Apollo EZ x-ray systems because the footrest detached from the table, causing a patient to fall.

    Product
    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1429-2017·2017-03-15

    Apollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard

    Villa Sistemi Medicali is recalling 65 Apollo DRF x-ray systems because the footrest can detach, causing patients to fall from the table.

    Product
    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1436-2017·2017-03-15

    Siemens Medical Linear Accelerators Recalled for Defective Overhead Suspension Welds

    Siemens is recalling 35 linear accelerator systems due to defective weld seams that could cause overhead suspensions to fall, posing a risk of severe injury.

    Product
    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1434-2017·2017-03-15

    Siemens Medical Linear Accelerators Recalled for Defective Weld Seams

    Siemens is recalling 35 MEVATRON M 6730/6740 linear accelerators because defective weld seams on overhead suspensions could break and fall, posing a risk of severe injury.

    Product
    MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1408-2017·2017-03-15

    FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise

    The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.

    Product
    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1409-2017·2017-03-15

    FDA Recalls Premier Guard Drape Due to Sterility Compromise

    The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.

    Product
    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0513-2017·2017-03-15

    McKesson Recalls Aspirin Chewable Tablets Due to Foreign Material

    McKesson Packaging Services is recalling 6,717 cartons of 81 mg Aspirin Chewable Tablets because foreign material was found in the bulk inventory.

    Product
    Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0492-2017·2017-03-15

    Mylan Recalls Mirtazapine Tablets Due to Foreign Glipizide Contamination

    Mylan Pharmaceuticals is recalling Mirtazapine tablets because bottles may contain foreign Glipizide 10 mg tablets. Consumers should stop using the product and contact their pharmacist.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1583-2017·2017-03-15

    Index Fresh Recalls Hass Avocados Due to Listeria Contamination Risk

    Index Fresh is recalling specific lots of Hass avocados because they may be contaminated with Listeria monocytogenes.

    Product
    Hass Avocado HA LB Signature Farms 15/4 60 1- USA Hass Avocado HA LTP S 60 1 Index Fresh- USA Hass Avocado HA RPCFB 10/4 70 1 Index Fresh- USA Hass Avocado HA LTP 32 2 So Good- USA
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1567-2017·2017-03-15

    Grove Fresh Apple Juice Recalled for Undeclared Milk Allergen

    Dairy Maid Dairy is recalling Grove Fresh Pasteurized Apple Juice from concentrate due to undeclared milk, a major allergen.

    Product
    Grove Fresh Pasteurized Apple Juice from concentrate, 4-ounce cartons, 100 % Pure.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1569-2017·2017-03-15

    Hormel Recalls Great Shake Fortified Nutrition Drinks for Undeclared Milk

    Hormel Foods is recalling Great Shake and Great Shake Plus fortified nutrition drinks due to the presence of undeclared milk.

    Product
    Great Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1406-2017·2017-03-15

    Prism Medical A625 Patient Lifts Recalled for Premature Strap Failure

    Prism Medical is recalling 76 A625 patient lifts because two units had straps break prematurely during internal testing at maximum load.

    Product
    A-series lift - A625 Manual Part No. 324117. Prism Medical.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1568-2017·2017-03-15

    Hormel Recalls Great Shake Drinks Due to Undeclared Milk

    Hormel Foods is recalling Great Shake and Great Shake Plus fortified nutrition drinks because they contain undeclared milk.

    Product
    Great Shake Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1414-2017·2017-03-15

    Becton Dickinson Recalls EpiCenter Plus Software Version 6.20A

    Becton Dickinson is recalling EpiCenter Plus Microbiology Data Management System software version 6.20A because outdated translation tables may cause mis-identification of organisms.

    Product
    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter sys
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1399-2017·2017-03-15

    Parker Medical Recalls Left Double Lumen Endobronchial Tubes

    Parker Medical is recalling specific lots of Left Double Lumen Endobronchial Tubes because the single lung isolation feature did not function as intended.

    Product
    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V182000·2017-03-15

    Ride The Ducks Recalls Amphibious Vehicles Due to Seat Belt Defect

    Ride The Ducks International LLC is recalling 1996-2014 amphibious vehicles because driver seats and seat belts may not secure occupants in a crash.

    Product
    RIDE THE DUCKS — RIDE THE DUCKS AMPHIBIOUS VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1584-2017·2017-03-15

    Trader Joe's Lemon Curd Recalled for Undeclared Milk Allergen

    Trader Joe's is recalling Imported English Authentic Lemon Curd because it contains undeclared milk in the butter ingredient.

    Product
    Trader Joes Imported English Authentic Lemon Curd, 10.5oz (300g), 24 jars/case
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-1571-2017·2017-03-15

    Hormel Recalls Great Shake Plus Drinks for Undeclared Milk

    Hormel Foods is recalling Great Shake and Great Shake Plus fortified nutrition drinks due to the presence of undeclared milk.

    Product
    Great Shake Plus Fortified Nutrition, Soy Formula, Vanilla Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-1570-2017·2017-03-15

    Hormel Recalls Great Shake Soy Formula Due to Undeclared Milk

    Hormel Foods is recalling Great Shake and Great Shake Plus soy formula drinks because they contain undeclared milk.

    Product
    Great Shake Fortified Nutrition, Soy Formula, Vanilla Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-1566-2017·2017-03-15

    Private Selection Salted Caramel Chocolate Almond Pie Recalled for Allergen Mislabeling

    Legendary Baking is recalling Private Selection Salted Caramel Chocolate Almond Pie because the label failed to list eggs and almonds as ingredients.

    Product
    Private Selection, Salted Caramel Chocolate Almond Pie, NET WT 34 OZ ( 2 LB 2 OZ) 963g, UPC 1111054021. Container: In a labeled pie dome and base. Pies are distributed frozen. Some stores sell refrigerated and some sell frozen.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1421-2017·2017-03-15

    Siemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results

    Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2017·2017-03-15

    See Clear Company Recalls Color Contact Lenses for Sterility and Labeling Issues

    The See Clear Company is recalling 119,829 units of color contact lenses because they may not be sterile and may have incorrect lot numbers or expiry dates.

    Product
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1581-2017·2017-03-15

    Index Fresh Recalls Hass Avocados Due to Listeria Contamination Risk

    Index Fresh is recalling specific lots of Hass avocados because they may be contaminated with Listeria monocytogenes.

    Product
    Hass Avocado 32 1 Index Fresh- USA Hass Avocado 36 1 Index Fresh- USA Hass Avocado 40 1 Index Fresh- USA Hass Avocado 48 1 Index Fresh- USA Hass Avocado 60 1 Index Fresh- USA Hass Avocado 70 1 Index Fresh- USA
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1572-2017·2017-03-15

    Hormel Recalls Great Shake Plus Drinks for Undeclared Milk

    Hormel Foods is recalling Great Shake Plus fortified nutrition drinks because they contain undeclared milk. Consumers with this product should stop using it.

    Product
    Great Shake Plus Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-1582-2017·2017-03-15

    Index Fresh Recalls Avocados Due to Listeria Contamination Risk

    Index Fresh is recalling 116 cases of Hass avocados distributed in California, Utah, and Washington because they may be contaminated with Listeria monocytogenes.

    Product
    Hass Avocado HA LTP S 40 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1575-2017·2017-03-15

    Robert Rothschild Farm Recalls Gift Sets with Chocolate Pretzel Dippers

    Robert Rothschild Farm LLC is recalling Gift Sets with Chocolate Pretzel Dippers because the product is not labeled with an ingredient statement, failing to declare the allergens soy and wheat.

    Product
    Gift Sets with Chocolate Pretzel Dippers
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1532-2017·2017-03-15

    Pharmanex ageLOC TR90 Protein Boost Recalled for Undeclared Milk Allergen

    Nu Skin is voluntarily recalling Pharmanex ageLOC TR90 Protein Boost because it contains an undeclared milk allergen.

    Product
    Pharmanex ageLOC TR90 Protein Boost. Protein Powder. Net wt. 1.59 lbs (720g). 30 Servings. Natural Vanilla Flavor. Lactose, Gluten, & Soy Free. Plant Protein/Vegetarian.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2017·2017-03-15

    Encore Medical Recalls RSP Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 626 RSP Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

    Product
    RSP Impaction Fixture
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1420-2017·2017-03-15

    Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference

    Siemens is recalling IMMULITE Progesterone test kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1573-2017·2017-03-15

    Hormel Recalls Great Shake Plus Drinks Due to Undeclared Milk

    Hormel Foods is recalling Great Shake Plus fortified nutrition drinks because they contain undeclared milk, a major food allergen.

    Product
    Great Shake Plus Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1405-2017·2017-03-15

    Prism Medical A625 Manual Lifts Recalled for Premature Strap Breakage

    ErgoSafe Products is recalling 21 Prism Medical A625 manual lifts because two units had straps break prematurely during internal testing at maximum load.

    Product
    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1576-2017·2017-03-15

    Stubb's Barbecue Sauce Recalled for Glass Bottle Defects

    McCormick & Co. is voluntarily recalling 18oz bottles of Stubb's Sticky Sweet BBQ Sauce due to glass defects that may cause chipped or missing glass.

    Product
    McCormick & Co., Inc., Stubbs Barbecue. 18oz Best By Date of January 17, 2020.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2017·2017-03-15

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Juno DRF x-ray systems because the footrest can detach from the table, causing patients to fall.

    Product
    Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2017·2017-03-15

    Boston Scientific Recalls AngioJet Ultra 5000 A Console Foot Switches

    Boston Scientific is recalling AngioJet Ultra 5000 A Console foot switches because they may stick during use, causing the device to operate continuously and undesirably.

    Product
    AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, to
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1424-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.

    Product
    Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2017·2017-03-15

    Teva Recalls Risedronate Sodium Tablets Due to Dissolution Failures

    Teva Pharmaceuticals is recalling Risedronate Sodium Delayed-release Tablets because stability testing revealed low out-of-specification dissolution results.

    Product
    Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2017·2017-03-15

    Sandoz Recalls Pioglitazone and Glimepiride Tablets Due to Dissolution Failure

    Sandoz Inc is recalling specific lots of Pioglitazone and Glimepiride Tablets because they failed to meet dissolution specifications.

    Product
    Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2017·2017-03-15

    Actavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure

    Actavis Inc is recalling specific lots of Levofloxacin Ophthalmic Solution because the product failed impurity specifications for a related compound.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2017·2017-03-15

    Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure

    Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.

    Product
    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1419-2017·2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1431-2017·2017-03-15

    Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures

    Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2017·2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2017·2017-03-15

    LEO Pharma Recalls Calcipotriene Cream Due to Labeling Errors

    LEO Pharma is recalling 272,062 tubes of Calcipotriene Cream because the label omitted a required excipient and a warning about contact dermatitis.

    Product
    CALCIPOTRIENE — CALCIPOTRIENE (CALCIPOTRIENE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2017·2017-03-15

    Remel Haemophilus Test Medium Recalled for Poor Organism Growth

    Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.

    Product
    Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2017·2017-03-15

    Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

    Product
    Turon Impaction Fixture
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1407-2017·2017-03-15

    MicroAire K-Wires Recalled for Incorrect Product Labeling

    MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.

    Product
    MicroAire K-Wires
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1422-2017·2017-03-15

    Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions

    Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.

    Product
    Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

    Product
    Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1426-2017·2017-03-15

    Merge Unity PACS Software Recalled for Missing Demographic Data

    Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1402-2017·2017-03-15

    Metrex Recalls CaviWipes Extra Large Due to Packaging Contamination

    Metrex Research is recalling CaviWipes Extra Large surface disinfectants because they may have been contaminated during the packaging process.

    Product
    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra La
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1411-2017·2017-03-15

    Mako Surgical Recalls MAKO RIO THA Application User Guides

    Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.

    Product
    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1403-2017·2017-03-15

    Merge Cardio software recalled for incorrect measurement units in reports

    Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1423-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.

    Product
    Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1410-2017·2017-03-15

    Integra UNI-CP System Recalled for Incorrect Labeling

    Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System due to incorrect labeling on the plate.

    Product
    The UNI-CP System; Model Number: 330230SND.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1416-2017·2017-03-15

    US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch

    US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.

    Product
    Roth Net Polyp Retrieval
    Category
    Medical Device
    Distribution
    15 states
  • SevereNHTSA·17V174000·2017-03-14

    Navistar Recalls International Trucks Due to Air Dryer Bracket Fracture Risk

    Navistar is recalling 2016-2018 International heavy diesel trucks because a mounting bracket may fracture, causing air leaks and increased stopping distance.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, LT, RH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V173000·2017-03-14

    Volvo Bus Recalls 2016-2017 9700 Models for Engine Stall Risk

    Volvo Bus is recalling 2016-2017 9700 transit buses because a ground cable may be improperly installed, causing the engine to stall unexpectedly.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V175000·2017-03-14

    Altec Recalls 2015-2016 Aerial Devices and Service Body Trucks

    Altec is recalling 2015-2016 Aerial Devices and Service Body Trucks due to a wiring defect that may cause a short circuit and increase fire risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE, SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V178000·2017-03-14

    Mercedes-Benz Recalls 2016 G550 and G63 Due to Door Cable Defect

    Mercedes-Benz is recalling 2016 G550 and G63 vehicles because a door cable may break, preventing occupants from opening the door from inside after a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G550, G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V167000·2017-03-14

    Jayco Recalls 2017 Designer Fifth Wheels Due to Spare Tire Rubbing

    Jayco is recalling 2017 Designer fifth wheel trailers because the spare tire rim may rub against the brake caliper, increasing crash risk.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL DESIGNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V177000·2017-03-14

    Mercedes-Benz Recalls Vehicles Due to Potential Air Bag Deployment Issues

    Mercedes-Benz is recalling various models because incorrect software in control units may prevent air bags from deploying correctly in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ C250, C300, C350, CLS550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V171000·2017-03-14

    Forest River Cherokee Recalled for Incorrect Federal Tire Placard Information

    Forest River is recalling 2017 Cherokee recreational trailers because the Federal Placard lists incorrect tire and rim sizes, which may lead to installing wrong replacement tires.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17109·2017-03-14

    Energizer XBOX ONE 2X Smart Chargers Recalled Due to Burn Hazard

    Performance Designed Products is recalling Energizer XBOX ONE 2X Smart Chargers because they can overheat and damage controllers, posing a burn risk.

    Product
    Energizer® XBOX ONE 2X Smart Chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V176000·2017-03-14

    Mercedes-Benz Recalls 2017 E300 Models for Front Passenger Air Bag Defect

    Mercedes-Benz is recalling 2017 E300 and E300 4Matic vehicles because the front passenger air bag may not deploy properly in certain seating positions, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E017000·2017-03-13

    Roush Propane Conversion Kit Recall for Fuel Valve Short Circuit

    Roush CleanTech is recalling Generation 4 Propane Conversion Kits because a fuel control valve solenoid may short circuit, causing the engine to shut off while driving.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V170000·2017-03-13

    Roush-Modified Ford Propane Vehicles Recalled for Fuel Valve Defect

    Roush CleanTech is recalling 2015-2017 modified Ford E-450, F59, F-650, and F-750 vehicles because a fuel control valve solenoid may short circuit, causing the engine to shut off while driving.

    Product
    FORD — FORD F59 ROUSH PROPANE, F-650 ROUSH PROPANE, F-750 ROUSH PROPANE, E-450 ROUSH PROPANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V161000·2017-03-13

    Maserati Recalls 2017 Levante Models Due to Engine Software Defect

    Maserati is recalling 2017 Levante vehicles because an engine software issue may cause the transmission to shift into neutral or the engine to shut off at slow speeds.

    Product
    MASERATI — MASERATI LEVANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V160000·2017-03-13

    Spartan Trucks Recalled for Front Suspension Ball Joint Separation Risk

    Spartan Motors is recalling specific 2011-2018 trucks because front suspension ball joints can loosen, potentially causing a loss of steering control.

    Product
    SPARTAN — SPARTAN K4, METROSTAR, K3, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V168000·2017-03-13

    Ford Recalls 2017 Mustangs for Door Handle Spring Defect

    Ford is recalling 2017 Mustangs because the driver-side door handle spring may loosen, allowing the door to unlatch in a crash.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V162000·2017-03-13

    Thor Motor Coach Recalls 2014-2016 Motorhomes for Wiper Defect

    Thor Motor Coach is recalling specific 2014-2016 motorhomes because improperly installed windshield wipers may fail, impairing visibility and increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MOTOR DAYBREAK, ACE, CHALLENGER, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V166000·2017-03-13

    Thor Motor Coach Recalls 2017 Motorhomes Due to Missing Seat Belts

    Thor Motor Coach is recalling 2017 Chateau, Freedom Elite, and Four Winds motorhomes because the middle sofa seat may lack a seat belt, increasing crash injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM ELITE, FOUR WINDS, CHATEAU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V165000·2017-03-13

    Ride The Ducks Recalls Amphibious Vehicles for Instrument Cluster Defect

    Ride The Ducks International LLC is recalling 1996-2014 amphibious vehicles because the instrument cluster fails to properly illuminate turn signal and high beam indicators, potentially increasing crash risk.

    Product
    RIDE THE DUCKS — RIDE THE DUCKS AMPHIBIOUS VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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