The Recall Desk

Archive

May 2016 recalls

603 recalls were announced in May 2016.

What the numbers show

Critical
27
Severe
108
High
210
Moderate
211
Low
47

Of the 603 recalls this month scored against our rubric, 4% are Critical, 18% are Severe.

201–300 of 603

  • HighNHTSA·16V315000·2016-05-18

    Lakota Luxe Trailers Recalled for Microwave Fire Risk

    Lakota is recalling 2014 Luxe trailers because the built-in microwave may start on its own, posing a fire hazard.

    Product
    LAKOTA — LAKOTA LUXE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1323-2016·2016-05-18

    Salsa Dianne Lemon Pesto Sauce Recalled for Undeclared Milk Allergen

    Salsa Dianne is recalling Lemon Pesto Sauce because the label declares parmesan cheese but fails to declare milk, a major allergen.

    Product
    Lemon Pesto Sauce, net wt. 4 oz. (113 g). Product is packaged in a round Styrofoam containers with translucent plastic lid. The UPC is 8 20103 77213 6. The product is labeled in parts: "***Lemon Pesto***INGREDIENTS: Olive Oil, Lemon, Almonds, Garlic, Parmesan cheese, Cilantr
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1325-2016·2016-05-18

    CVS Gold Emblem Organic Spiced Herbal Tea Recalled for Salmonella

    CVS Health is recalling Gold Emblem Abound Organic Spiced Herbal Tea because the product contains Salmonella. Consumers should stop using the product.

    Product
    Gold Emblem Abound Organic Spiced Herbal Tea, 20 TEA BAGS, NET WT 1.41 OZ (40g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V321000·2016-05-18

    Daimler Trucks Recalls 2012-2015 FCCC Motorhome Chassis for Brake Defect

    Daimler Trucks North America is recalling 2,275 FCCC motorhome chassis due to a throttle sensor issue that may prevent the engine brake from activating, increasing crash risk.

    Product
    FCCC — FCCC XCL, XCP, XCM, XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E047000·2016-05-18

    Cummins Recalls ISX12 and ISX15 Engines for Electrical Module Defect

    Cummins is recalling specific ISX12 and ISX15 engines due to a potential Engine Control Module short circuit that may cause the engine to stall without warning.

    Product
    ELECTRICAL SYSTEM:IGNITION:MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2016·2016-05-18

    Recall of Given Imaging Bravo pH Capsule Delivery Devices

    Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and chi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2016·2016-05-18

    Novarad NovaPACS Diagnostic Viewer Recalled for Incorrect SUV Calculations

    Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.

    Product
    NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 145 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, posing a risk to patients in hospital settings.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1617-2016·2016-05-18

    C.R. Bard Recalls Arctic Sun Temperature Management Systems

    C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.

    Product
    Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1662-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely low results.

    Product
    Dimension Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16163·2016-05-18

    phil&teds Recalls Dash Strollers Due to Hinge Pinch Hazard

    phil&teds is recalling about 630 Dash v5 strollers in the U.S. because the folding hinge can become damaged, posing a pinch hazard to consumers.

    Product
    phil&teds dash strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2016·2016-05-18

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges due to open well instability that may cause inaccurate test results.

    Product
    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry s
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1626-2016·2016-05-18

    Stryker Launcher Guiding Catheter Recalled for Unsealed Packaging

    Stryker is recalling two units of the Launcher Guiding Catheter because the device packaging may not be sealed.

    Product
    Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1652-2016·2016-05-18

    Siemens LDL Cholesterol Assay Recalled for Interference

    Siemens is recalling Advia Chemistry Assay: LDL Cholesterol, Direct because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: LDL Cholesterol, Direct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2016·2016-05-18

    Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2016·2016-05-18

    Sesderma Sunscreen Recalled for cGMP Deviations

    Sesderma is recalling 45 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0852-2016·2016-05-18

    Baxter Recalls Brevibloc Injection Due to Yellow Discoloration

    Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.

    Product
    BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2016·2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen for cGMP Deviations

    Sesderma is recalling 66 bottles of Repaskin 50 sunscreen due to cGMP deviations. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0840-2016·2016-05-18

    Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.

    Product
    Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0846-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling Dryses Aluminum Chlorohydrate Deodorant for Men because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0845-2016·2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 20 bottles of Repaskin 30 sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0844-2016·2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations

    Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

    Product
    Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1659-2016·2016-05-18

    Siemens Direct HDL Cholesterol Assay Recalled for Interference

    Siemens is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: Direct HDL Cholesterol (AHDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2016·2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0851-2016·2016-05-18

    Sesderma Sunscreen Recalled for cGMP Non-Compliance

    Sesderma is recalling 44 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1638-2016·2016-05-18

    Ascom Mobile Monitoring Gateway and Nurse Call Software Recall

    Ascom US, INC. is recalling 319 units of Mobile Monitoring Gateway and Unite Connect for Nurse Call due to a software malfunction that prevents automatic message forwarding if the primary module fails.

    Product
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-1625-2016·2016-05-18

    Mallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging

    Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.

    Product
    Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0841-2016·2016-05-18

    Dr. Reddy's Recalls Ondansetron Tablets Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, due to failed impurities and degradation specifications.

    Product
    Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1618-2016·2016-05-18

    Siemens Syva Emit Methotrexate Assay Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate values.

    Product
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateUSDA FSIS·041-2016·2016-05-18

    Aurnish Pork Dumplings Recalled for Undeclared MSG

    Aurnish Enterprises is recalling pork dumplings because they contain monosodium glutamate (MSG) that is not listed on the label.

    Product
    Recall Notification Report 041-2016 (Pork Dumpling Products)
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1627-2016·2016-05-18

    Baxter GEM Flowcoupler Recall Due to Packaging Puncture Risk

    Baxter Healthcare is recalling 315 units of GEM Flowcoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 630 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2016·2016-05-18

    Siemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1622-2016·2016-05-18

    Siemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista BUN Flex reagent cartridges because they may produce inaccurate patient or quality control results.

    Product
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2016·2016-05-18

    Sesderma Salises Acne Gel Recalled for cGMP Deviations

    Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.

    Product
    Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1631-2016·2016-05-18

    Baxter GEM FlowCoupler Recalled Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 118 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2016·2016-05-18

    Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations

    Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1650-2016·2016-05-18

    Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall

    Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.

    Product
    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1658-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Interference

    Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1644-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1629-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 707 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1645-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1615-2016·2016-05-18

    Siemens ADVIA Centaur CP Immunoassay System Recalled for Documentation Errors

    Siemens Healthcare Diagnostics is recalling the ADVIA Centaur CP Immunoassay System because inaccuracies in the Operator's Guide may cause sample processing issues when using EZee-Nest Insert Cups.

    Product
    ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1643-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error

    Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1640-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphyl
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1647-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·16V309000·2016-05-17

    Eldorado Transit Bus Recall for Seat Separation Risk

    Eldorado is recalling 2016 Advantage and Aerotech transit buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    ELDORADO — ELDORADO AEROTECH, ADVANTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V312000·2016-05-17

    Kia Recalls 2013 Fortes Due to Front Seatbelt Retainer Defect

    Kia is recalling 2013 Fortes because front seatbelt retractor screws may be loose. This could cause the retractor plate to break in a crash, striking occupants.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V308000·2016-05-17

    Mercedes-Benz Recalls 2016 AMG GT S for Driveshaft Bond Failure

    Mercedes-Benz is recalling 136 model year 2016 AMG GT S vehicles because the carbon-fiber driveshaft bond may fail, causing loss of torque and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E045000·2016-05-17

    Bendix SR-5 Trailer Spring Brake Valves Recalled for Parking Brake Delay

    Bendix is recalling SR-5 Trailer Spring Brake Valves manufactured between January 2014 and March 2016 because improper machining may delay spring brake application, increasing the risk of trailers rolling away.

    Product
    PARKING BRAKE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V313000·2016-05-17

    Spartan K3 and MM Motorhome Chassis Recalled for Exhaust Fire Risk

    Spartan is recalling 2007-2015 K3 and MM motorhome chassis because a torn flexible exhaust tube may allow hot gas to contact other components, increasing fire risk.

    Product
    SPARTAN — SPARTAN K3, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V310000·2016-05-17

    Collins Recalls 2016 School Buses Due to Seat Separation Risk

    Collins Bus Corporation is recalling 2016 DH416 and DE516 school buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    COLLINS — COLLINS DH416, DE516
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V311000·2016-05-17

    BMW Recalls 2011 X5 and X6 Models for Driveshaft Defect

    BMW is recalling 21,493 2011 X5 and X6 vehicles because a front driveshaft joint may fail, increasing crash risk.

    Product
    BMW — BMW X6 ACTIVEHYBRID SAC, X5 DIESEL SAV, X5, X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16162·2016-05-17

    Pacific Cycle Recalls Infant Bicycle Helmets Due to Choking and Magnet Hazards

    Pacific Cycle is recalling about 129,000 infant bicycle helmets sold at Target because loose magnetic buckle parts pose choking and ingestion risks to young children.

    Product
    Infant bicycle helmets with magnetic no-pinch buckle chin straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16159·2016-05-17

    Target Recalls Acrylic Hanukkah Menorahs Due to Fire Hazard

    Target is recalling clear acrylic Hanukkah menorahs because they can melt when candles are burning, posing a fire hazard. No injuries or property damage have been reported.

    Product
    Menorahs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalNHTSA·16E044000·2016-05-16

    Takata Frontal Passenger Air Bag Inflator Recall for Specific States

    Takata is recalling specific frontal passenger air bag inflators used in vehicles registered in 22 states due to a risk of rupture.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V304000·2016-05-16

    Jayco Recalls 2016 Jay Flight SLX Trailers Due to Propane Tank Bolt Defect

    Jayco is recalling 2016 Jay Flight SLX travel trailers because missing lock washers may allow the propane tank to detach, increasing crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V302000·2016-05-16

    Fiat 500 Recall: Manual Transmission Clutch Spring May Fracture

    Chrysler is recalling 2012-2016 Fiat 500 vehicles with manual transmissions because the clutch diaphragm spring may fracture, potentially preventing gear shifting.

    Product
    FIAT — FIAT 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V306000·2016-05-16

    Mercedes-Benz Recalls 2016 SLK300 Vehicles for Rear Tie Rod Defect

    Mercedes-Benz is recalling 327 model year 2016 SLK300 vehicles because improperly manufactured lock nuts on the rear wheel tie rods may cause the rear axle to steer independently, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SLK300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E042000·2016-05-16

    Takata Frontal Passenger Air Bag Inflator Rupture Recall

    Takata is recalling specific frontal passenger air bag inflators that may rupture due to humidity and heat exposure, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E041000·2016-05-16

    Chrysler Recalls Mopar Canvas Seat Covers for RAM Trucks

    Chrysler is recalling aftermarket Mopar canvas seat covers for 2012-2016 RAM trucks because they can impede airbag deployment, increasing injury risk in a crash.

    Product
    DODGE — DODGE, RAM RAM 1500, 1500, 3500, RAM 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V300000·2016-05-16

    Chrysler Recalls 2016 Minivans for Loose Third Row Seatback Nuts

    Chrysler is recalling 2016 Dodge Grand Caravan and Town and Country minivans because third row seatback nuts may be loose, posing an injury risk.

    Product
    DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V297000·2016-05-13

    Quality Trailers Recalls 2015 Flatbed and Wedge Car Haulers for Axle Defect

    Quality Trailers is recalling 2015 Flatbed Equipment and Wedge Car Hauler trailers because axle lock nuts may loosen, potentially causing the axle to detach and increasing crash risk.

    Product
    QUALITY — QUALITY WEDGE CAR HAULER, EQUIPMENT FLATBED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E040000·2016-05-13

    ZF Front Axle Recall for Steering Connection Wear Risk

    ZF North America is recalling certain RL 77 and RL 80 EM axle assemblies due to incorrect internal spacers that can cause premature wear in the steering connection.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V299000·2016-05-13

    Supreme Recalls 2007-2009 Silver Crown and Ponyxpress RVs for Step Defect

    Supreme Corporation is recalling 2007-2009 Silver Crown and Ponyxpress vehicles because a bolt on the electric entry steps may fracture, causing the steps to become unstable.

    Product
    SUPREME — SUPREME PONYXPRESS, SILVER CROWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V298000·2016-05-13

    Supreme Classic American Trolley Recall for Seat Belt Anchor Weld Defect

    Supreme is recalling 2010-2016 Classic American Trolley vehicles because missing welds on seat brackets may allow seat belt anchors to separate, increasing injury risk in a crash.

    Product
    SUPREME — SUPREME CLASSIC AMERICAN TROLLEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·027-2016 expansion-3·2016-05-13

    Pilgrim's Pride Recalls Chicken Products Due to Foreign Matter Contamination

    Pilgrim's Pride is expanding a recall of fully cooked chicken products due to possible contamination with extraneous metal materials.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corp. Expands Recall of Poultry Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V295000·2016-05-12

    Champion Challenger Shuttle Buses Recalled for Seat Separation Risk

    Champion is recalling 2016 Challenger shuttle buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    CHAMPION — CHAMPION CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V294000·2016-05-12

    Kovatch Mobile Equipment Recalls Firefighting Vehicles Due to Pump Strainer Defect

    Kovatch Mobile Equipment is recalling certain 2016-2017 emergency vehicles because pump intake strainers may be improperly soldered, potentially causing pump damage and reduced firefighting effectiveness.

    Product
    NAVISTAR — NAVISTAR, KME 4400, 7400, PREDATOR SS, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V293000·2016-05-12

    E-One Recalls 2015-2016 Emergency Vehicles Due to Pump Strainer Defect

    E-One is recalling 140 model year 2015-2016 Cyclone II, Quest II, and Typhoon emergency vehicles because pump intake strainers may be improperly soldered.

    Product
    E-ONE — E-ONE CYCLONE II, QUEST II, TYPHOON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V296000·2016-05-12

    Supreme Recalls 2011-2014 Vans Due to Fire Risk in Marker Lights

    Supreme Corporation is recalling 2011-2014 Signature Van, Iner-City, and Kold King vehicles because roof marker lights may short circuit and cause the corner caps to catch fire.

    Product
    SUPREME — SUPREME SIGNATURE VAN, INER-CITY, KOLD KING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1318-2016·2016-05-11

    Back To Nature Classic Creme Cookies Recalled for Undeclared Milk

    Back To Nature Foods is recalling Classic Creme Cookies because they contain undeclared milk. The recall covers 154,044 cartons shipped to 16 states.

    Product
    Classic Creme Cookies, Net wt. 12 oz cartons, 6 cartons per case. Manufactured for Back To Nature Foods Co., LLC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1320-2016·2016-05-11

    Kroger Raw Macadamia Nuts Recalled Due to Salmonella Contamination

    The Kroger Company is recalling raw macadamia nuts after positive Salmonella test results. Consumers should check their pantries for the specific UPC and sell-by date.

    Product
    Kroger Raw #4 Macadamia Nuts. UPC 2 04192 51053 2 Dist. by the Kroger Company Cincinnati, Ohio 45202
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-1535-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1291-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonellosis Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling specific lots of Trader Joe's pistachios due to a link with a current Salmonellosis outbreak.

    Product
    Dry Roasted & Unsalted Inshell Pistachios; Packaged for Trader Joe's. Packaged in 16 oz. bag. UPC 00079990
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1308-2016·2016-05-11

    International Sprout Holding Recalls Alfalfa Seed Due to Salmonella

    International Sprout Holding Inc. is recalling 39,909 lbs of alfalfa seed because one sample tested positive for Salmonella Poly B.

    Product
    ALFALFA SEED, NET WT. 50 LB. International Specialty Supply LLC, Cookeville, TN
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1292-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonellosis Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling specific lots of Trader Joe's pistachios due to a link with a current Salmonellosis outbreak.

    Product
    Dry Roasted & Salted Inshell Pistachios; Packaged for Trader Joe's. Packaged in 16 oz. bag. UPC 00079983
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1285-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonella Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling roasted inshell pistachios linked to a Salmonellosis outbreak. The recall covers products distributed in the US, Canada, Mexico, and Peru.

    Product
    Roasted No Salt Inshell Pistachios: Packaged under brand name of Wonderful. Packed in 16 oz., 8 oz., 200 grams and 225 grams bags. UPC - 16 oz: 014113910064 UPC - 8 oz:.014113910187 UPC - 200 grams: 014113913652 UPC - 225 grams: 014113912532
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1286-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonella Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling roasted salt and pepper inshell pistachios due to a link with a current outbreak of Salmonellosis.

    Product
    Roasted Salt and Pepper Inshell Pistachios: Packaged under brand name of Wonderful. Packed in 4.50oz. bag. UPC - Bag 014113910293, Outer Box UPC: 014113913362
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1288-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonellosis Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling roasted salted shelled pistachios linked to a current Salmonellosis outbreak.

    Product
    Roasted Salted Shelled Pistachios Packaged under brand name of Wonderful Packed in 6 oz.., 2.5 oz., 24 oz., 6 oz., 225 g bags. UPC - 6 oz. bag 014113734066 UPC 2.5 oz. bag 014113910132 Outer box UPC 014113913386 UPC 24 oz bag 014113910125 UPC 6 oz. bag 0141137
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1287-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonellosis Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling roasted salted inshell pistachios linked to a current Salmonellosis outbreak.

    Product
    Roasted Salted Inshell Pistachios: Packaged under brand name of Wonderful, Paramount Packed in 1.5 oz., 24 oz., 5 oz., 13 oz., 40 oz., 1 oz,. bags and 25 lb. box. UPC - 1.5 oz. bag: 014113911856 Outer Box UPC: 014113911863 UPC 24 oz. bag: 014113911979 UPC 5 oz. bag:
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1289-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonella Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling Roasted Sweet Chili Pistachios because they were produced in a facility linked to a current Salmonellosis outbreak.

    Product
    Roasted Sweet Chili Pistachios Packaged under brand name of Wonderful Packed in 1.25 oz., 4.5 oz. bags. UPC - 1.25 oz bag 014113913331; Outer box UPC 014113913348 UPC 4.5 oz bag 014113910309 Outer box UPC 014113913379
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1290-2016·2016-05-11

    Wonderful Pistachios Recalled Due to Salmonella Outbreak Link

    Wonderful Pistachios & Almonds, LLC. is recalling specific Trader Joe's pistachio products linked to a Salmonellosis outbreak.

    Product
    50% Less Salt Dry Roasted & Salted Inshell Pistachios; Packaged for Trader Joe's. Packaged in 16 oz. bag. UPC 00111348
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·16V284000·2016-05-11

    2016 Jeep Cherokee Recall for Right Halfshaft Fracture Risk

    Chrysler is recalling 2016 Jeep Cherokee vehicles because the right halfshaft may fracture without warning, increasing crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1531-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    Product
    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health ce
    Category
    Medical Device
    Distribution
    Distributed nationwide

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