The Recall Desk

Archive

April 2015 recalls

1,319 recalls were announced in April 2015.

What the numbers show

Critical
109
Severe
527
High
388
Moderate
278
Low
17

Of the 1,319 recalls this month scored against our rubric, 8% are Critical, 40% are Severe.

Which agencies issued them

1001–1100 of 1319

  • HighFDA (Food)·F-1870-2015·2015-04-08

    Mrs. Fields Macadamia Cookies Recalled for Allergen Labeling Error

    Interbake Foods is recalling Mrs. Fields White Chunk Macadamia Cookies because the packaging failed to declare the presence of the macadamia allergen as required by FALCPA.

    Product
    Mrs. Fields White Chunk Macadamia Cookies; 12 individually wrapped cookies in a tray/box; there are 6 trays/boxes to a case. Therefore there are 72 cookies in a case; 2.1 oz single size serving.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1797-2015·2015-04-08

    San Juan Salsa Recalls Six Varieties Due to Peanut Contamination

    San Juan Salsa Co. is recalling six varieties of salsa because they may contain peanuts. The salsa was distributed within Washington.

    Product
    Mild Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, "***SAN JUAN SALSA CO.***MILD***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***" UPC code: 7 18738 54632 4
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1822-2015·2015-04-08

    Florentina's Salsa Ranchera Recalled for Undeclared Peanuts

    Creative Foodworks is recalling Florentina's Gourmet Salsa Ranchera because it may contain undeclared peanuts.

    Product
    Florentina's Gourmet SALSA RANCHERA Medium Net Wt. 16 oz. (454g)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1832-2015·2015-04-08

    Austin Chile Co Guacamole Recalled for Undeclared Peanuts

    Creative Foodworks is recalling Austin Chile Co Guacamole Pablano Salsa due to undeclared peanuts. Consumers should check their pantries for the specific lot number.

    Product
    AUSTIN CHILE CO GUACAMOLE PABLANO SALSA MEDIUM NET ET. 16 OZ (453g)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1778-2015·2015-04-08

    Market of Choice Frozen Pork Meals Recalled for Undeclared Peanut

    Market of Choice is recalling specific frozen pulled pork meals due to the potential presence of undeclared peanut.

    Product
    Frozen Smoked Pulled Pork with Sweet Chili BBQ Sauce, Heat sealed frozen dinners, 16 oz and 29.6 oz UPC for 16 oz.: 12855005998 UPC for 29.6 oz: 1285400999
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1777-2015·2015-04-08

    Market of Choice Frozen Pork and Chicken Meals Recalled for Undeclared Peanut

    Market of Choice is recalling specific frozen pork and chicken meals due to the potential presence of undeclared peanut.

    Product
    Frozen Shredded Pork Enchilada Meal; Heat sealed frozen dinners,16 oz and 29.6 oz UPC for 16 ounce small is 12859007998, and UPC for 29.6 ounce large is 12858013990
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1816-2015·2015-04-08

    Texas Sting Hot Buffalo Wings Sauce Recalled for Undeclared Peanuts

    Creative Foodworks is recalling Texas Sting Hot Buffalo Wings Sauce because it may contain undeclared peanuts.

    Product
    TEXAS STING HOT BUFFALO WINGS SAUCE Manufactured for RB FOODS COMPANY NET 12 FL OZ (355ML)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1810-2015·2015-04-08

    Tastefully Simple Corn, Black Bean Salsa Recalled for Undeclared Peanuts

    Creative Foodworks, Inc. is recalling Tastefully Simple Corn, Black Bean Salsa because it may contain undeclared peanuts.

    Product
    Tastefully Simple Corn, Black Bean Salsa NET WT 16 OZ (454g); Distributed by Tastefully Simple, Inc. Alexandria, MN 56308
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1850-2015·2015-04-08

    Native Texan Picante Mild Recalled for Undeclared Peanuts

    Creative Foodworks, Inc. is recalling Native Texan Picante Mild due to undeclared peanuts. The product was distributed in five states.

    Product
    Native Texan Picante Mild NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1812-2015·2015-04-08

    Florentina's Salsa Ranchera Hot Recalled for Undeclared Peanuts

    Creative Foodworks, Inc. is recalling Florentina's Gourmet Salsa Ranchera Hot because it may contain undeclared peanuts.

    Product
    Florentina's Gourmet SALSA RANCHERA HOT Net Wt. 16 oz. (454g)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1858-2015·2015-04-08

    Texas Texas Gourmet Peach Medium Salsa Recalled for Undeclared Peanuts

    Creative Foodworks, Inc. is recalling Texas Texas Gourmet Peach Medium Salsa because it may contain undeclared peanuts.

    Product
    Texas Texas Gournet Peach Medium Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1802-2015·2015-04-08

    San Juan Salsa Recalls Pineapple Mango Salsa for Peanut Contamination

    San Juan Salsa Co. is recalling Pineapple Mango Salsa due to potential peanut contamination. The product was distributed within Washington.

    Product
    Pineapple Mango Salsa, 13 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, "***SAN JUAN SALSA CO.***Pineapple Mango Salsa***Keep Refrigerated***NET WT. 13 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***" UPC code: 7 187
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1801-2015·2015-04-08

    San Juan Salsa Recalls Six Varieties Due to Peanut Contamination

    San Juan Salsa Co. is recalling six varieties of salsa because they may contain peanuts. The products were distributed within Washington.

    Product
    Afterburner Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, "***SAN JUAN SALSA CO.***AFTERBURNER***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***" UPC code: 7 18738 54635 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1851-2015·2015-04-08

    Native Texan Hatch Chile Salsa Roja Recalled for Undeclared Peanuts

    Creative Foodworks, Inc. is recalling Native Texan Hatch Chile Salsa Roja Medium because the product may contain undeclared peanuts.

    Product
    Native Texan Hatch Chile Salsa Roja Medium NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1336-2015·2015-04-08

    Boston Scientific Recalls Expel Drainage Catheters Due to Fragmentation Risk

    Boston Scientific is recalling Expel APD and APDL Drainage Catheters after one report of device fragmentation in the biliary system.

    Product
    Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1346-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging

    Microtek Medical is recalling smoke evacuator tubing sets because the packaging contains latex but lacks the required warning label.

    Product
    TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operatin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2015·2015-04-08

    Edwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas

    Edwards Lifesciences is recalling specific sizes of the Fem-Flex II Pediatric Femoral Arterial Cannula due to a protruding wire at the tip that could cause tissue damage.

    Product
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2015·2015-04-08

    Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues

    Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.

    Product
    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2015·2015-04-08

    Leonhard Lang ECG Electrodes Recalled for Signal Transmission Failure

    Leonhard Lang is recalling specific lots of Skintact and Stable Base ECG electrodes because they may fail to transmit signals.

    Product
    Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1799-2015·2015-04-08

    San Juan Salsa Co. Recalls Six Salsa Varieties Due to Peanut Contamination

    San Juan Salsa Co. is recalling six varieties of salsa due to potential peanut contamination. The product was distributed within Washington.

    Product
    Hot Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, "***SAN JUAN SALSA CO.***HOT***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***" UPC code: 7 18738 54634 8
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1365-2015·2015-04-08

    Medtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach

    Medtronic is voluntarily recalling Trellis 6 and 8 Peripheral Infusion Systems due to potential sterility breaches in the outer packaging.

    Product
    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1787-2015·2015-04-08

    Crown Naturals Trail Mix Recalled for Undeclared FD&C Yellow #6

    Crown Food Distributor Inc. is recalling Crown Naturals Trail Mix because samples contained undeclared FD&C Yellow #6.

    Product
    Crown Naturals Trail Mix, Net Wt. 9 oz. (7.80 LB), Sale by: 10/9/2015, Product of USA, Packed by Crown Food, North Bergen, NJ 07047
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1672-2015·2015-04-08

    Health One Recalls Gentiana Combination Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling Gentiana Combination dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Gentiana Combination, 100 Vegetarian Capsules, 500mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1773-2015·2015-04-08

    Health One Pharmaceuticals Recalls Vigerect Dietary Supplements

    Health One Pharmaceuticals is recalling Vigerect dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Vigerect
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1710-2015·2015-04-08

    Health One Pharmaceuticals Recalls Cold Plus II Dietary Supplements

    Health One Pharmaceuticals is recalling Cold Plus II dietary supplements due to significant violations of current good manufacturing practices (cGMP) regulations.

    Product
    Cold Plus II, 30 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1339-2015·2015-04-08

    Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging

    Microtek Medical Inc is recalling 153 Freedomaire Surgical Helmets because the packaging contains latex but lacks the required warning label.

    Product
    FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contaminat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1642-2015·2015-04-08

    Health One Pharmaceuticals Recalls Tri-Circulator Dietary Supplement

    Health One Pharmaceuticals is recalling Tri-Circulator dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Tri- Circulator, 60 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1668-2015·2015-04-08

    Health One Pharmaceuticals Recalls In Act Xtract Dietary Supplements

    Health One Pharmaceuticals is recalling In Act Xtract dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    In Act Xtract
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1708-2015·2015-04-08

    Health One Pharmaceuticals Recalls Cholesterol Formula Due to cGMP Violations

    Health One Pharmaceuticals is recalling Cholesterol Formula capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

    Product
    Cholesterol Formula, 90 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1347-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging

    Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without the required warning label.

    Product
    (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1636-2015·2015-04-08

    Health One Pharmaceuticals Recalls Bone Essense Dietary Supplement

    Health One Pharmaceuticals is recalling Bone Essense, 60 capsules, due to significant violations of cGMP regulations for dietary supplements.

    Product
    Bone Essense, 60 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2015·2015-04-08

    Microtek Medical Recalls Sterile Vacuum Tubing Due to Unlabeled Latex Packaging

    Microtek Medical Inc is recalling sterile vacuum tubing because the packaging contains latex but lacks the required warning label.

    Product
    VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1637-2015·2015-04-08

    Health One Recalls Menopause Dietary Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling Best Women's Formula for Menopause capsules due to significant violations of cGMP regulations for dietary supplements.

    Product
    Best Women's Formula for Menopause, 90 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1689-2015·2015-04-08

    Health One Recalls Grape Skin Extract Complex Due to cGMP Violations

    Health One Pharmaceuticals is recalling Grape Skin Extract Complex capsules due to significant violations of dietary supplement manufacturing regulations.

    Product
    Grape Skin Extract Complex, 60 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1667-2015·2015-04-08

    Health One Pharmaceuticals Recalls Fish Collagen Dietary Supplements

    Health One Pharmaceuticals is recalling Fish Collagen dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Fish Collagen
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1766-2015·2015-04-08

    Health One Pharmaceuticals Recalls U Liver Pro Dietary Supplement

    Health One Pharmaceuticals is recalling U Liver Pro dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    U Liver Pro, 60 capsules, 300mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1653-2015·2015-04-08

    Health One Recalls True Woman Dietary Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling True Woman dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    True Woman, 60 Vege Capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1683-2015·2015-04-08

    Health One Pharmaceuticals Recalls SOD Herbal Mix for cGMP Violations

    Health One Pharmaceuticals is recalling SOD Herbal Mix dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    SOD Herbal Mix
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1677-2015·2015-04-08

    Health One Pharmaceuticals Recalls Optium Joint Rx Dietary Supplement

    Health One Pharmaceuticals is recalling Optium Joint Rx dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Optium Joint Rx, 90 Tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1652-2015·2015-04-08

    Health One Recalls Glucosamine Chondroitin MSM Supplements for cGMP Violations

    Health One Pharmaceuticals is recalling Glucosamine Chondroitin MSM dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Glucosamine Chondroitn MSM, 120 Vegetarian Capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1711-2015·2015-04-08

    Health One Pharmaceuticals Recalls Cordyceps Dietary Supplement

    Health One Pharmaceuticals is recalling Cordyceps dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Cordyceps, 180 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1749-2015·2015-04-08

    Health One Pharmaceuticals Recalls Protein Powder for cGMP Violations

    Health One Pharmaceuticals is recalling Protein Powder due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

    Product
    Protein Powder
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1360-2015·2015-04-08

    Zimmer Recalls Persona Anterior Referencing Sizers Due to Specification Nonconformance

    Zimmer, Inc. is voluntarily recalling 22 lots of Persona Anterior Referencing Sizers with Locking Boom because the devices do not conform to print specifications.

    Product
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer he
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Food)·F-1648-2015·2015-04-08

    Health One Pharmaceuticals Recalls Yin Vive Dietary Supplement

    Health One Pharmaceuticals is recalling Yin Vive dietary supplements due to significant violations of cGMP regulations.

    Product
    Yin Vive, 80 Veggie Capsules, 400mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2015·2015-04-08

    Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies

    Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.

    Product
    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1361-2015·2015-04-08

    King Systems Double Swivel Connector Recalled for Mislabeling

    King Systems Corp. is recalling 900 units of Double Swivel Connectors mislabeled as having a suction port. The error may cause a short procedure delay but poses no risk to patients.

    Product
    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2015·2015-04-08

    Microtek Smoke Evacuation Tubing Set Recalled for Latex Packaging Labeling Error

    Microtek Medical Inc is recalling 303 Smoke Evacuation Tubing Sets because the packaging contains latex but lacks the required warning label.

    Product
    Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2015·2015-04-08

    BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination

    BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.

    Product
    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1352-2015·2015-04-08

    Synthes Aiming Arms Recalled Due to Potential Jamming of Guide Sleeve

    Synthes, Inc. is recalling 131 Aiming Arms from the TFN-ADVANCED system because the guide sleeve may jam, potentially delaying instrument removal.

    Product
    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2015·2015-04-08

    Microtek Medical recalls sterile smoke evacuator wands due to latex packaging

    Microtek Medical is recalling sterile smoke evacuator wands because the packaging contains latex but lacks the required warning label.

    Product
    INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endosc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1340-2015·2015-04-08

    Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging

    Microtek Medical Inc is recalling 11 units of Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.

    Product
    FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contaminati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1691-2015·2015-04-08

    Health One Pharmaceuticals Recalls All Tonic Dietary Supplement

    Health One Pharmaceuticals is recalling All Tonic dietary supplements due to significant violations of cGMP regulations.

    Product
    All Tonic, 80 Veggie Capsules, 400 mg
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2015·2015-04-08

    Biologic Therapies Recalls Bio-PLASTY Cannulas for Misbranding

    Biologic Therapies, Inc. is recalling 58 Bio-PLASTY Cannulas because they were distributed without proper FDA clearance and classification.

    Product
    Bio-PLASTY Cannula (Needle)
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1374-2015·2015-04-08

    Biologic Therapies Recalls Bio-CORE Cannula Sets for Misbranding

    Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.

    Product
    Bio-CORE Cannula (Needle) Set
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1366-2015·2015-04-08

    Owen Mumford Autoject E1 Fixed Needle Device Recalled for Missing Components

    Owen Mumford USA, Inc. is recalling 3,100 Autoject E1 Fixed needle devices because the syringe carrier is missing a damper and spring.

    Product
    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1337-2015·2015-04-08

    Microtek Medical Recalls Freedomaire Surgical Helmet Systems Due to Latex Packaging

    Microtek Medical is recalling 10 Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.

    Product
    FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1706-2015·2015-04-08

    Health One Pharmaceuticals Recalls Cardiospecs Dietary Supplements

    Health One Pharmaceuticals is recalling Cardiospecs dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Cardiospecs
    Category
    Food
    Distribution
    Distributed nationwide

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