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.

301–400 of 854

  • HighFDA (Food)·F-1610-2017·2017-03-22

    Krispy Kreme Custard Filled Doughnuts Recalled for Metal Pieces

    Krispy Kreme Doughnut Corporation is recalling Choc Iced Custard Filled Doughnuts because they may contain foreign matter, specifically metal pieces.

    Product
    Krispy Kreme Doughnuts Choc Iced Custard Filled, 2 count boxes (UPC 0 72470 00000 2), 6 count boxes (UPC 0 72470 00206 8), Single served (UPC 004-06149-001).
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1593-2017·2017-03-22

    LBB Imports Recalls Thornton's Hollow Milk Chocolate Jolly Santa

    LBB Imports is recalling Thornton's Hollow Milk Chocolate Jolly Santa because it may contain a piece of plastic that poses a risk to consumers.

    Product
    Thornton's Hollow Milk Chocolate Jolly Santa, 200g, Barcode: 5016346234721
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1449-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Label

    LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2017·2017-03-22

    Acumed Orthopedic Guide Wires Recalled Due to Packaging Errors

    Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.

    Product
    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1442-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.

    Product
    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1479-2017·2017-03-22

    Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

    Product
    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.

    Product
    SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1397-2017·2017-03-22

    Toshiba Kalare X-ray Generator Recalled for Premature Exposure Termination

    Toshiba American Medical Systems Inc is recalling 254 Kalare DREX-KL80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Kalare DREX-KL80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0544-2017·2017-03-22

    Synergy Rx Recalls Trichloroacetic Acid Solutions Due to Sterility Concerns

    Synergy Rx is recalling Trichloroacetic Acid Solutions in various strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0590-2017·2017-03-22

    Synergy Rx Recalls Melatonin Spray Due to Sterility Assurance Concerns

    Synergy Rx is recalling Melatonin 1.5mg Spray because the product lacks assurance of sterility and has CGMP deviations.

    Product
    MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1588-2017·2017-03-22

    Goulibeur Shortbread Recalled for Missing Milk Allergen Labeling

    Goulibeur is recalling 240 units of pure butter shortbreads because the packaging fails to identify milk as an allergen source for the butter ingredient.

    Product
    Goulibeur - Pack of 15 pure butter shortbreads in 3 freshness packs Net weight 9.87 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1602-2017·2017-03-22

    Sweets & Desserts Recalls Cheesecake for Undeclared Allergens and Colors

    Sweets & Desserts, Inc. is recalling Cheesecake Parcha (Passion Fruit) in Puerto Rico due to undeclared milk, food colors, and aspartame.

    Product
    The Sweet Dessert Corp., Cheesecake Parcha (Passion Fruit), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1447-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·029-2017·2017-03-22

    Whiskey Hill Smokehouse Recalls Jerky for Undeclared Soy Allergen

    Whiskey Hill Smokehouse is recalling beef, venison, and ostrich jerky because the products contain soy, a known allergen, that is not declared on the label.

    Product
    Whiskey Hill Smokehouse LLC — Whiskey Hill Smokehouse LLC. Recalls Beef, Venison and Ostrich Jerky Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2017·2017-03-22

    Synergy Rx Recalls Tretinoin Cream and Gel Due to Sterility Concerns

    Synergy Rx is recalling Tretinoin Cream and Gel in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in all strengths including 0.1% and 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2017·2017-03-22

    Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors

    Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.

    Product
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1605-2017·2017-03-22

    Choice Farms Portabella Mushrooms Recalled for Listeria Risk

    Del Monte Fresh Produce is recalling Choice Farms Pizza Style Portabella Mushrooms due to possible Listeria monocytogenes contamination.

    Product
    Choice Farms Pizza Style Portabella Mushrooms 8 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1599-2017·2017-03-22

    Sweets & Desserts Recalls Cheesecake Guayaba for Undeclared Milk and Color

    Sweets & Desserts, Inc. is recalling Cheesecake Guayaba products due to undeclared milk and food color Red #40. The recall affects 2,000 units distributed in Puerto Rico.

    Product
    The Sweet Dessert Corp., Cheesecake Guayaba (Guava), Peso Neto (Net Weight) 3oz and 4oz and 4oz (large label)., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1611-2017·2017-03-22

    Krispy Kreme Chocolate Iced Sprinkle Theme Recalled for Metal Pieces

    Krispy Kreme Doughnut Corporation is recalling 717 units of Chocolate Iced Sprinkle Theme donuts because they may contain metal pieces.

    Product
    Krispy Kreme Chocolate Iced Sprinkle Theme, 6 count boxes (UPC 0 72470 00029 3), Single served (UPC 004-02300-001).
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1587-2017·2017-03-22

    Goulibeur Shortbread Recalled for Missing Milk Allergen Labeling

    Goulibeur is recalling 200 units of shortbread in Maryland because the packaging lists butter but fails to identify milk as an allergen source.

    Product
    Goulibeur Cube tin box with pictures of France, containing small pure butter shortbreads Net weight 4.23 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1600-2017·2017-03-22

    Sweets & Desserts Recalls Cheesecake Fresa for Undeclared Allergens

    Sweets & Desserts, Inc. is recalling Cheesecake Fresa (Strawberry) in Puerto Rico due to undeclared milk and Red #40 food color.

    Product
    The Sweet Dessert Corp., Cheesecake Fresa (Strawberry), Peso Neto (Net Weight) 3 oz and 4 oz (small labels)3 and 4oz (large label), Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0575-2017·2017-03-22

    Synergy Rx Recalls TRI-BLEACHING CREAM Due to Sterility Assurance Issues

    Synergy Rx is recalling TRI-BLEACHING CREAM because it lacks assurance of sterility and has CGMP deviations. The product is distributed nationwide.

    Product
    TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1591-2017·2017-03-22

    Goulibeur Shortbread Cookies Recalled for Missing Milk Allergen Labeling

    Goulibeur is recalling 250 units of pure butter shortbreads sold in Maryland because the packaging lists butter but fails to identify milk as an allergen source.

    Product
    Goulibeur  2 pure butter shortbreads in a freshness bag Net weight 1.76 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1607-2017·2017-03-22

    Choice Farms Stuffed Mushrooms Recalled for Listeria Contamination

    Del Monte Fresh Produce is recalling Choice Farms Stuffed Mushrooms due to possible Listeria monocytogenes contamination. The product was distributed in Texas and Kansas.

    Product
    CHOICE FARMS Stuffed Mushrooms, 7 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1586-2017·2017-03-22

    Goulibeur Shortbread Recalled for Missing Milk Allergen Labeling

    Goulibeur is recalling 150 units of butter shortbread with flaked almonds because the packaging fails to identify milk as an allergen source for the butter ingredient.

    Product
    Goulibeur - Large pure butter shortbread with flaked almonds, in neutral gift wrapping Net weight 13.5 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1481-2017·2017-03-22

    Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.

    Product
    882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1590-2017·2017-03-22

    Goulibeur Shortbread Recalled for Missing Milk Allergen Labeling

    Goulibeur is recalling 800 units of Life in Paris shortbread because the packaging lists butter but fails to identify milk as an allergen source.

    Product
    Goulibeur- Cube tin box Life in Paris, containing mini heart-shaped pure butter shortbreads Net weight 4.23 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0570-2017·2017-03-22

    Synergy Rx Recalls Reverse DML Lotion Due to Sterility Assurance Issues

    Synergy Rx is recalling all lots of Reverse DML Lotion because the product lacks assurance of sterility and has CGMP deviations.

    Product
    REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2017·2017-03-22

    Toshiba Ultimax X-ray generator recalled for premature exposure termination

    Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Ultimax DREX-ULT80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0586-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Hydroquinone Cream in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2017·2017-03-22

    Synergy Rx Recalls Firm and Fade Cream Due to Sterility Concerns

    Synergy Rx is recalling Firm and Fade cream because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·17V196000·2017-03-22

    Audi Recalls 2017 A3 and S3 Vehicles for Air Bag Software Defect

    Volkswagen Group of America is recalling 2017 Audi A3 and S3 vehicles because the air bag control software may deploy the passenger air bag improperly in lower-speed crashes.

    Product
    AUDI — AUDI S3, A3 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1601-2017·2017-03-22

    Sweets & Desserts Recalls Cheesecake Piña for Undeclared Milk and Food Color

    Sweets & Desserts, Inc. is recalling 850 units of Cheesecake Piña (Pineapple) in Puerto Rico due to undeclared milk and food colors Yellow #5 and Yellow #6.

    Product
    The Sweet Dessert Corp., Cheesecake Pi¿a (Pineapple), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0529-2017·2017-03-22

    Synergy Rx Recalls Bicarbonate 10% Due to Sterility Assurance Concerns

    Synergy Rx is recalling Bicarbonate 10% because the product lacks assurance of sterility and has CGMP deviations.

    Product
    BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0561-2017·2017-03-22

    Synergy Rx Recalls Jessner's Peel Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of Jessner's Peel because the product lacks assurance of sterility and has CGMP deviations.

    Product
    JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1608-2017·2017-03-22

    Krispy Kreme Doughnuts Recalled for Potential Metal Foreign Matter

    Krispy Kreme Doughnuts Choc Iced Glazed are being recalled due to potential metal pieces. The recall affects specific boxes and single-serve units produced on February 6, 2017.

    Product
    Krispy Kreme Doughnuts Choc Iced Glazed, 2 count boxes (UPC 0 72470 00003 3), 6 count boxes (UPC 0 72470 00226 6), Single served (UPC 004-01155-001).
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1464-2017·2017-03-22

    CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports

    CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.

    Product
    MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1603-2017·2017-03-22

    Sweets & Desserts Recalls Tres Leches Cakes for Undeclared Food Colors

    Sweets & Desserts, Inc. is recalling Tres Leches cakes in Puerto Rico because they contain undeclared food colors.

    Product
    The Sweet Dessert Corp., Tres Leches (Three Milk Cake), Peso Neto (Net Weight) 3oz and 4 oz., and 4oz (large label) Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0539-2017·2017-03-22

    Synergy Rx Recalls Glycolic Acid Products Due to Sterility Concerns

    Synergy Rx is recalling specific glycolic acid prescription products due to a lack of assurance of sterility and CGMP deviations.

    Product
    GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2017·2017-03-22

    Synergy Rx Recalls Retinoic Acid Solution Due to Sterility Concerns

    Synergy Rx is recalling all lots of Retinoic Acid Solution due to a lack of assurance of sterility and CGMP deviations.

    Product
    RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1467-2017·2017-03-22

    Siemens Artis Zee and Zeego Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Zee and Zeego fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Zee and Zeego fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1478-2017·2017-03-22

    Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal

    Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.

    Product
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for cov
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1468-2017·2017-03-22

    Siemens Axiom Artis Fluoroscopic X-Ray System Recalled for Foot Switch Housing Gap

    Siemens is recalling Axiom Artis fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Axiom Artis fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1471-2017·2017-03-22

    Ortho-Clinical VITROS Lithium Slides Recalled for Imprecision

    Ortho-Clinical Diagnostics is recalling specific lots of VITROS Lithium Slides due to intermittent imprecision in test results.

    Product
    VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1463-2017·2017-03-22

    Radiometer ABL800 Blood Gas Analyzer Recall for Sample Type Change

    Radiometer America Inc. is recalling ABL800 analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'

    Product
    The ABL800 Model#:All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1448-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2017·2017-03-22

    GE OEC FlexiView 8800 Imaging System Recalled for Power Cord Failures

    GE is recalling OEC FlexiView 8800 systems where specific power cords were replaced in 2016 due to intermittent failures causing loss of imaging functionality.

    Product
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1444-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 608 Reddick Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1459-2017·2017-03-22

    Terumo Level Sensor Gel Pads Recalled for Non-Compliant Labeling

    Terumo is voluntarily recalling Level Sensor II Gel Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1451-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2017·2017-03-22

    Synergy Rx Fluocinonide Solution Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Fluocinonide 0.05% Solution due to a lack of assurance of sterility and CGMP deviations.

    Product
    FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0589-2017·2017-03-22

    Synergy Rx Recalls Tretinoin Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream because of a lack of assurance of sterility and CGMP deviations.

    Product
    TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2017·2017-03-22

    Synergy Rx Recalls RETIN-A 0.05% Cream Due to Sterility Concerns

    Synergy Rx is recalling RETIN-A 0.05% Cream because of a lack of assurance of sterility and CGMP deviations.

    Product
    RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1445-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1450-2017·2017-03-22

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 4,673 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1466-2017·2017-03-22

    Siemens Artis Q and Q.Zen Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Q and Q.Zen fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Q and Q.Zen fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1480-2017·2017-03-22

    Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

    Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

    Product
    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2017·2017-03-22

    Synergy Rx Recalls Metronidazole and Azelaic Acid Products for Sterility Concerns

    Synergy Rx is recalling Metronidazole 1% Gel and Metronidazole/Niacinamide/Azelaic Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1457-2017·2017-03-22

    Merge Hemo software recalled due to study tab locking issue

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.

    Product
    Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1458-2017·2017-03-22

    Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling

    Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1441-2017·2017-03-22

    RTI Biologics BioSet IC RT Paste Recalled for Incorrect Instructions

    RTI Surgical is recalling 24 units of BioSet IC RT Paste due to incorrect instructions for use. The product was distributed in Colombia.

    Product
    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1462-2017·2017-03-22

    Radiometer ABL90 Flex Analyzer Recalled for Sample Type Labeling Change

    Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'

    Product
    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2017·2017-03-22

    Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes

    Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.

    Product
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0587-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone 28% Solution Due to Sterility Concerns

    Synergy Rx is recalling Hydroquinone 28% Solution because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0558-2017·2017-03-22

    Synergy Rx Recalls Generic VI Peel Due to Sterility Concerns

    Synergy Rx is recalling Generic VI Peel products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1597-2017·2017-03-22

    Batch International Recalls Chocolate Truffles Due to Allergen Labeling

    Batch International LLC is recalling assorted chocolate truffles because allergens are listed on an internal insert rather than the exterior box.

    Product
    Assorted chocolate truffles, packaged in Kraft colored boxes with the Batch PDX sticker. Boxes contain 5, 8, 12, 18, 24 or 32 pieces with any combination of the following 14 flavors: 1. Vietnamese Iced Coffee 2. Raspberry 3. Spicy Passion 4. Bull Run Bourbon 5. Mint M
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1453-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2017·2017-03-22

    Synergy Rx Recalls Betamethasone Creams and Ointments for Sterility Concerns

    Synergy Rx is recalling various betamethasone cream and ointment products due to a lack of assurance of sterility and CGMP deviations.

    Product
    BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%/ 10%/
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1604-2017·2017-03-22

    Sweets & Desserts Recalls Tres Leches Chocolate for Undeclared Food Dyes

    Sweets & Desserts, Inc. is recalling 200 units of Tres Leches Chocolate in Puerto Rico due to undeclared food dyes.

    Product
    The Sweet Dessert Corp., Tres Leches Chocolate (Three Milk Cake with chocolate), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0520-2017·2017-03-22

    Amerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure

    Amerisource Health Services is recalling specific lots of Glipizide Extended-Release tablets because they failed to meet dissolution specifications.

    Product
    GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2017·2017-03-22

    Synergy Rx Enhanced Retin Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Enhanced Retin Anti-Wrinkle Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0603-2017·2017-03-22

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Labeling Error

    Pharmedium Services, LLC is recalling 3,879 syringes of Buffered Lidocaine because the outer packaging is incorrectly labeled as 1% instead of 0.9%.

    Product
    Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0521-2017·2017-03-22

    PreviDent Toothpaste Recalled for Incorrect Rear Panel Labeling

    Colgate is recalling 14,656 bottles of PreviDent 5000 toothpaste because the rear panel is incorrectly labeled with text from a different product.

    Product
    PREVIDENT — PREVIDENT (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2017·2017-03-22

    Pfizer Recalls PROTONIX IV Vials for Subpotent Potency

    Pfizer is recalling 582,165 vials of PROTONIX IV (pantoprazole sodium) because the drug failed potency testing at the 6-month stability time point.

    Product
    PROTONIX — PROTONIX (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1439-2017·2017-03-22

    Smiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message

    Smiths Medical ASD, Inc. is recalling 20 CADD Solis VIP Ambulatory Infusion Pumps sold in Finland due to a mistranslated error message. The pump's function is unchanged, and no patient injury can occur.

    Product
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1454-2017·2017-03-22

    Bencox Mirabo PE Liner Recalled for Incorrect Instruction Manual

    Corentec Co., Ltd. is recalling five units of Bencox Mirabo PE Liners distributed in Pennsylvania because they may contain Chinese instructions instead of US instructions.

    Product
    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0519-2017·2017-03-22

    G&W Laboratories Recalls Clindamycin Phosphate Topical Solution Due to Expired Ingredient

    G&W Laboratories is recalling specific lots of Clindamycin Phosphate Topical Solution because an expired active ingredient was used during manufacturing.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavi
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2017·2017-03-21

    J & Y Dasung Recalls Frozen Pork Dumplings Produced Without Inspection

    J & Y Dasung, Inc. is recalling approximately 178,335 pounds of frozen pork dumplings produced without federal inspection. The products were shipped to retail locations in Southern California.

    Product
    J & Y Dasung, Inc. Recalls Pork Dumpling Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V191000·2017-03-21

    Isuzu Recalls NPR, NQR, and NRR Trucks for Loose Wheel Bolts

    Isuzu is recalling 2011-2017 NPR, NQR, and NRR trucks because left rear wheel bearing hub locking bolts may be loose, increasing crash risk.

    Product
    ISUZU — ISUZU NRR, NQR, NPR, NPR XD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17112·2017-03-21

    Polaris Recalls Sportsman 850 and 1000 ATVs for Burn and Fire Hazards

    Polaris is recalling about 19,200 Sportsman 850 and 1000 ATVs because heat shields can melt and exhaust springs can stretch, posing burn and fire risks.

    Product
    Sportsman 850 and 1000 all-terrain vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V192000·2017-03-21

    Fiat 500L Recall: Powertrain Software Limits Engine Acceleration

    Chrysler is recalling 2014 Fiat 500L vehicles because incorrect Powertrain Control Module software may limit engine speed and torque, increasing crash risk.

    Product
    FIAT — FIAT 500L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V197000·2017-03-21

    Fleetwood and Holiday Rambler RVs Recalled for Incorrect Tire Placards

    REV Recreation Group is recalling 2017 Fleetwood Bounder and Holiday Rambler Vacationer RVs because Federal Placards list the wrong tire size.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER BOUNDER, VACATIONER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·027-2017·2017-03-19

    H & B Packing Recalls Boneless Beef Due To E. coli O103 Contamination

    H & B Packing Co. is recalling approximately 79,461 pounds of boneless beef products produced on March 6, 2017, due to possible E. coli O103 contamination.

    Product
    H & B Packing Co. Inc. — H & B Packing Co., Inc. Recalls Boneless Beef Products Due To Possible E. coli O103 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·023-2017 EXP·2017-03-17

    King's Command Foods Recalls Beef Products Due To Foreign Matter

    King's Command Foods is recalling approximately 63,252 pounds of ground beef products, including meatballs and beef fritters, due to possible contamination with extraneous materials such as metal.

    Product
    King's Command Foods, LLC — King's Command Foods, LLC. Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V187000·2017-03-17

    Entegra Motorhomes Recalled for Front Suspension Ball Joint Separation Risk

    Entegra is recalling specific Aspire, Cornerstone, and Anthem motorhomes because front suspension ball joints may loosen and separate, potentially causing a loss of steering control.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE, ANTHEM, ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V189000·2017-03-17

    BMW Recalls 2017 X5 Models Due to Air Bag Inflator Defect

    BMW is recalling 2017 X5 vehicles because the passenger air bag inflator may not vent properly, potentially causing metal fragments to strike occupants in a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide

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