The Recall Desk

Archive

February 2014 recalls

473 recalls were announced in February 2014.

What the numbers show

Critical
14
Severe
98
High
222
Moderate
120
Low
19

Of the 473 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

101–200 of 473

  • ModerateFDA (Devices)·Z-1001-2014·2014-02-26

    Zimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues

    Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1037-2014·2014-02-26

    Zimmer Recalls FEM HD ION Hip Implants Due to Packaging Validation Issues

    Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    FEM HD ION (various sizes)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2014·2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1540-2014·2014-02-26

    Abbott Nutrition Recalls Similac Human Milk Fortifier Powder Packets

    Abbott Nutrition is recalling Similac Human Milk Fortifier Powder packets in Canada due to incomplete seals that may allow air entry, causing oxidation or powder leakage.

    Product
    Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1036-2014·2014-02-26

    Zimmer Recalls CPT Degree Taper and Femoral HD Medical Devices

    Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.

    Product
    CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1043-2014·2014-02-26

    Zimmer Recalls 3.5 Compression Plates Due to Packaging Validation Issues

    Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations were not properly validated, despite passing seal integrity tests.

    Product
    3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1478-2014·2014-02-26

    Dried Tapioca Pearls Recalled for Unapproved and Undeclared Colors

    New Japan International, Inc. is recalling dried tapioca pearls containing unapproved and undeclared colors. The product was distributed in ten states.

    Product
    Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1004-2014·2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

    Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2014·2014-02-26

    Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1014-2014·2014-02-26

    Zimmer Recalls One-Piece Lag Screws Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2014·2014-02-26

    Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues

    Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2014·2014-02-26

    Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer

    Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.

    Product
    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1005-2014·2014-02-26

    Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues

    Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1025-2014·2014-02-26

    Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues

    Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.

    Product
    HGP II ACETABULAR CUP BON
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2014·2014-02-26

    Zimmer Recalls Compression Screws Due to Packaging Validation Review

    Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2014·2014-02-26

    Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations

    Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2014·2014-02-26

    Zimmer Recalls Trilogy Acet Shell and Bone Screw Medical Devices

    Zimmer is recalling Trilogy Acet Shell and Bone Screw devices due to unvalidated packaging operations at its Puerto Rico facility.

    Product
    TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2014·2014-02-26

    Zimmer Recalls NEXGEN Osteotomy Cortical Bone Screws Due to Packaging Validation

    Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1009-2014·2014-02-26

    Zimmer Recalls Interlocking IM Screws and Tibial Nails Due to Packaging Validation

    Zimmer is recalling interlocking IM screws and tibial nails sterile packaged at a Puerto Rico facility because packaging operations were not properly validated.

    Product
    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1013-2014·2014-02-26

    Zimmer Recalls ITST Anti-Rotation Screws and Femoral Intramedullary Nails

    Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.

    Product
    ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2014·2014-02-26

    Zimmer Recalls Asia One-Piece Lag Screws Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 Asia One-Piece Lag Screws because packaging operations at a Puerto Rico facility were not properly validated, potentially affecting sterile barrier integrity.

    Product
    ASIA ONE-PIECE LAG SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1015-2014·2014-02-26

    Zimmer Recalls Orthopedic Implants Due to Packaging Validation Deficiencies

    Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1031-2014·2014-02-26

    Zimmer Recalls 12/14 Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1017-2014·2014-02-26

    Zimmer Recalls Hip Prostheses Due to Packaging Validation Issues

    Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2014·2014-02-26

    Zimmer Recalls Modular Hip Implants Due to Packaging Validation Issues

    Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2014·2014-02-26

    Zimmer Recalls Modular Austin Moore Femoral Neck Implants Due to Packaging Validation

    Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2014·2014-02-26

    Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings

    Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.

    Product
    Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1006-2014·2014-02-26

    Zimmer Recalls Versa-FX Orthopedic Implants Due to Packaging Validation Issues

    Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·016-2014·2014-02-26

    Santa Maria Foods Recalls Various Meat Products Lacking Full USDA Inspection

    Santa Maria Foods is recalling approximately 8,895 pounds of various meat products because they were imported without full USDA inspection. No illnesses have been reported.

    Product
    Canadian Firm Recalls Various Meat Products Without Import Inspection
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1019-2014·2014-02-26

    Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0992-2014·2014-02-26

    Synthes Matrix Mandible Short Threaded Drill Guide Recall for Labeling Error

    Synthes, Inc. is recalling 12 units of Matrix Mandible Short Threaded Drill Guides because they have a gray band instead of the green band shown in the guide.

    Product
    Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
    Category
    Medical Device
    Distribution
    3 states
  • SevereCPSC·14115·2014-02-25

    BRP Recalls Ski-Doo and Can-Am Heated Gloves Due to Fire Hazard

    BRP is recalling Ski-Doo and Can-Am heated gloves and lithium-ion batteries because the battery packs can overheat and cause fires. No injuries were reported, but minor property damage occurred.

    Product
    Ski-Doo® and Can-Am® heated gloves and Lithium-Ion Rechargeable Batteries.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V081000·2014-02-25

    NABI Recalls 2013-2014 Buses Due to Intake Manifold Freeze Risk

    NABI is recalling 269 city transit buses because condensation in the intake manifold may freeze, potentially causing exhaust flames or vehicle fire.

    Product
    NABI — NABI LFW, BRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14114·2014-02-25

    Genie Recalls Garage Door Openers Due to Fire Hazard

    Genie is recalling specific screw drive garage door openers because the control board can overheat, posing a fire hazard. No injuries have been reported.

    Product
    Garage door openers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14113·2014-02-25

    Rollerblade USA Recalls Tempest Inline Skates Due to Fall Hazard

    Rollerblade USA is recalling about 11,800 pairs of Tempest inline skates because misaligned mounting holes can cause the boot to separate from the frame, posing a fall hazard.

    Product
    Rollerblade® Tempest Inline Skates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V073000·2014-02-24

    Prevost Recalls 2008-2010 X3-45 Coaches Due to Fire Risk

    Prevost is recalling 2008-2010 X3-45 coaches because a specific DC to DC converter potting compound may conduct electricity and cause a fire.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V078000·2014-02-21

    Mack Trucks Recalls 70,208 Vehicles for Electrical Fire Risk

    Mack Trucks is recalling 70,208 vehicles from model years 2007-2015 because water leaks may contaminate the Electronic Power Distribution Module, increasing the risk of a fire.

    Product
    MACK — MACK CHU, TD, GU, GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V082000·2014-02-21

    Kalmar Recalls 2010-2013 Ottawa Terminal Tractors Due to Fire Risk

    Kalmar is recalling certain 2010-2013 Ottawa terminal tractors because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames that increase the risk of fire or burn injury.

    Product
    OTTAWA — OTTAWA TERMINAL TRACTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V079000·2014-02-21

    Daimler Recalls Thomas Built Buses Due to Intake Manifold Sensor Defect

    Daimler is recalling 2009-2015 Thomas Built Saf-T-Liner HDX school buses because condensation in the intake manifold may freeze, causing sensor malfunction and increasing the risk of fire or burn injury.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V092000·2014-02-21

    GM Recalls 2014 Vehicles for Transmission Shift Cable Defect

    General Motors is recalling 2014 Buick, Chevrolet, and GMC vehicles because the transmission shift cable may disengage, creating a risk of the vehicle rolling away.

    Product
    CHEVROLET — CHEVROLET, BUICK, GMC IMPALA, VERANO, TRAVERSE, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V080000·2014-02-21

    Daimler Trucks Recalls 2008-2015 Vehicles Due to Intake Manifold Defect

    Daimler Trucks North America is recalling specific 2008-2015 Freightliner, Sterling, and Thomas Built Buses vehicles because condensation in the intake manifold may freeze, causing sensor malfunction and increasing the risk of fire or burn injury.

    Product
    FREIGHTLINER — FREIGHTLINER, THOMAS BUILT BUSES, STERLING CASCADIA, M2, SAF-T-LINER HDX, LT8500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V088000·2014-02-21

    Mack LEU Trucks Recalled for Exhaust Pipe Disconnection Risk

    Mack is recalling 2010-2015 LEU trucks with Cummins ISL engines because the exhaust pipe may disconnect, potentially exposing operators to carbon monoxide.

    Product
    MACK — MACK LEU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V067000·2014-02-20

    Etnyre Recalls 2012 Trailers Due to Slack Adjuster Housing Defect

    E.D. Etnyre & Co. is recalling 2012 asphalt, heavy haul, and live bottom trailers because defective slack adjusters may crack, causing loss of braking and potential crashes.

    Product
    ETNYRE — ETNYRE ASPHALT TRAILER, HEAVY HAUL TRAILER, LIVE BOTTOM TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V068000·2014-02-20

    Caterpillar Recalls CT660 Trucks Due to Brake Bracket Fracture Risk

    Caterpillar is recalling 2012-2013 CT660 trucks because brake S-cam brackets may fracture, potentially causing the vehicle to pull or increase stopping distance.

    Product
    CATERPILLAR — CATERPILLAR CT660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V076000·2014-02-20

    Intercontinental Truck Cube Van Door Lock Recall for Jamming Risk

    Intercontinental Truck Body is recalling 2010-2013 Cube Vans because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    INTERCONTINENTAL TRUCK — INTERCONTINENTAL TRUCK CUBE VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14110·2014-02-20

    U.S. Polo Assn. Recalls Girl's Jackets Due to Strangulation Hazard

    U.S. Polo Assn. is recalling girl's jackets because a neck band poses a strangulation hazard to young children. No injuries have been reported.

    Product
    U.S. Polo Assn. girl's jackets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14108·2014-02-20

    Sterling Rope Recalls Sewn Cords Due to Fall Hazard

    Sterling Rope Company is recalling specific sewn cord products because they may break at lower weights than published, posing a fall hazard.

    Product
    Sewn cord edge restraints, sewn eyes and sewn loops.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14109·2014-02-20

    Infantino Recalls Teething Toys Due to Choking Hazard

    Infantino is recalling Go Gaga Squeeze & Teethe Coco the Monkey teething toys because the tail poses a choking hazard to young children.

    Product
    Go Gaga Squeeze & Teethe Coco the Monkey
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·14111·2014-02-20

    Eastman Recalls Coleman Runestone Children's Shoes Due to Sharp Edges

    Eastman Footwear is recalling Coleman Runestone children's shoes because metal rivets may have sharp edges that can cause lacerations. Consumers should stop using the shoes and return them for a refund.

    Product
    Coleman® Runestone Style Children's Shoes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1479-2014·2014-02-19

    Braum's Panko Bread Crumbs Recalled for Undeclared Milk

    Braum's Ice Cream and Dairy is recalling Panko Style Bread Crumbs because they contain undeclared milk. The product was distributed in five states.

    Product
    Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1488-2014·2014-02-19

    Kinnikinnick Frozen Waffles Recalled for Undeclared Milk

    Unified Western Grocers is recalling Kinnikinnick Gluten Free Original Homestyle Waffles because they contain undeclared milk despite being labeled as dairy-free.

    Product
    Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1474-2014·2014-02-19

    Paskesz Belgian Chocolate Coins Recalled for Undeclared Milk

    Paskesz Candy Co. is recalling Premium Belgian Chocolate coins due to undeclared milk. The recall covers 2,334 cases distributed nationwide.

    Product
    PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g) packaged in a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178. MADE IN HOLLAND FOR: P
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1486-2014·2014-02-19

    Kinnikinnick Gluten-Free Bread Crumbs Recalled for Undeclared Milk

    Unified Western Grocers is recalling Kinnikinnick Gluten Free Bread Crumbs Panko Style due to undeclared milk, despite labels indicating the product is dairy-free.

    Product
    Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz. UPC 62013360015 3 2
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0964-2014·2014-02-19

    Stryker Accolade Broach Handle Recalled Due to Impaction Plate Fracture

    Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.

    Product
    Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-1494-2014·2014-02-19

    Natures Best Recalls Waffles and Pancakes for Undeclared Milk

    Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk. The recall is nationwide.

    Product
    Original Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001981, NB Item #616953
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2014·2014-02-19

    Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk

    Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.

    Product
    T:slim Insulin Delivery System Insulin Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1477-2014·2014-02-19

    Gano Excel Recalls Spirulina Sachets for Undeclared Wheat and Soy

    Gano Excel USA is recalling Gano C'Real Spirulina sachets because they contain undeclared wheat and soy allergens.

    Product
    Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V065000·2014-02-19

    BMW Recalls 2013 Motorcycles Due to Side-Stand Switch Water Ingress

    BMW is recalling 4,453 model year 2013 motorcycles because water may enter the side-stand switch, potentially causing the engine to shut off while riding.

    Product
    BMW — BMW F800 GS, R1200 GS, R 1200 R, C650 GT MAXI-SCOOTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1473-2014·2014-02-19

    Mira Health Recalls Bolt Fat Incenerator Capsules Due to DMAA

    Mira Health Products Ltd. is recalling Bolt Fat Incenerator capsules because they contain DMAA, a banned ingredient.

    Product
    Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0945-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1481-2014·2014-02-19

    Araya Gourmet Chocolate Bars Recalled for Undeclared Allergens

    Araya, Inc. is recalling specific gourmet chocolate bars nationwide because they may contain undeclared allergens. Consumers should check their packages for the listed UPC codes.

    Product
    Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1480-2014·2014-02-19

    Windsor Frozen Foods Recalls Gorgonzola Gems Jalapeno Peppers Due to Listeria Risk

    Windsor Frozen Foods is recalling Gorgonzola Gems Jalapeno Peppers because the product has the potential to be contaminated with Listeria monocytogenes.

    Product
    Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0948-2014·2014-02-19

    Ecolab Recalls Vital Care Ultrasound Probe Covers Due to Testing Deficiencies

    Ecolab Inc is recalling specific lots of Vital Care ultrasound probe covers because they did not undergo endotoxin testing to the proper levels.

    Product
    Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2014·2014-02-19

    Natures Best Recalls Waffles and Pancakes for Undeclared Milk

    Natures Best is recalling Kinnikinnick pancake and waffle products because they contain undeclared milk.

    Product
    Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item #616961.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2014·2014-02-19

    Araya Marshmallows Recalled for Undeclared Allergens

    Araya, Inc. is recalling various flavored marshmallows because they may contain undeclared allergens. The recall covers wholesale and internet sales nationwide.

    Product
    Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2014·2014-02-19

    Boston Scientific Recalls Coyote PTA Balloon Dilatation Catheters

    Boston Scientific is recalling Coyote PTA Balloon Dilatation Catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0938-2014·2014-02-19

    Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage

    Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.

    Product
    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical impl
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0947-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1484-2014·2014-02-19

    Araya Chocolate Gift Boxes Recalled for Undeclared Allergens

    Araya, Inc. is recalling specific chocolate gift boxes nationwide because they may contain undeclared allergens. Consumers should stop using these products.

    Product
    Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo endotoxin testing to the proper levels.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1475-2014·2014-02-19

    Farm To Market Bread Co. Sourdough Recalled for Undeclared Wheat

    Farm To Market Bread Co. is recalling San Francisco Sourdough bread because the label fails to list wheat flour, an undeclared allergen.

    Product
    Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C. Farm to Market Bread Co., Kansas City, MO.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0979-2014·2014-02-19

    Philips Gemini TF Big Bore PET/CT Systems Recalled for Mechanical Binding

    Philips is recalling 47 Gemini TF Big Bore PET/CT systems because the patient table can mechanically bind, causing an automatic emergency stop and incomplete scans.

    Product
    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1485-2014·2014-02-19

    Araya Chocolate S'mores Recalled for Undeclared Allergens

    Araya, Inc. is recalling Chocolate S'mores because the product may contain undeclared allergens. The recall covers 2,264 wholesale units and internet sales distributed nationwide.

    Product
    Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2014·2014-02-19

    McKesson Recalls Horizon Medical Imaging PACS Software Due to Archive Errors

    McKesson Information Solutions LLC is recalling 618 units of Horizon Medical Imaging PACS software because images may be archived to incorrect locations, causing display failures.

    Product
    Horizon Medical Imaging, Picture Archive Communication System (PACS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1476-2014·2014-02-19

    Kellogg Recalls Pringles Original Cans Due to Undeclared Milk Allergen

    Kellogg is recalling Pringles Original cans because they contain undeclared milk, a major food allergen. Consumers with milk allergies should not eat the product.

    Product
    Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code 0 38000 84496 6 Ingredients: INGREDIENTS: DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFL
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2014·2014-02-19

    Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing

    Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.

    Product
    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0967-2014·2014-02-19

    Brainlab VectorVision Spine Instrument Star Unit ML Recall

    Brainlab is recalling 25 VectorVision Spine Instrument Star Unit ML devices because pins may be made of incorrect material, posing a risk of corrosion and particle release during surgery.

    Product
    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1487-2014·2014-02-19

    Kinnikinnick Gluten-Free Pancake and Waffle Mix Recalled for Undeclared Milk

    Unified Western Grocers is recalling Kinnikinnick Gluten Free Pancake and Waffle Mix due to undeclared milk, despite the label indicating the product is dairy free.

    Product
    Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 g/ 16 oz UPC 62013300512 2
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1496-2014·2014-02-19

    Natures Best Recalls Bread and Bun Mix Due to Undeclared Milk

    Natures Best is recalling Bread & Bun Mix products because they contain undeclared milk, a major food allergen.

    Product
    Bread & Bun Mix, 16.4oz, Qty/pkg: 6, UPC 620133105504, NB Item 645564
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2014·2014-02-19

    Boston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues

    Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1489-2014·2014-02-19

    Kinnikinnick Frozen Waffles Recalled for Undeclared Milk Allergen

    Unified Western Grocers is recalling Kinnikinnick frozen waffles due to undeclared milk, despite labels indicating the product is dairy-free.

    Product
    Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten free, dairy free, nut free. 210 g/7.4oz Qty/pkg - 6 UPC 62013300199 8
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1492-2014·2014-02-19

    Natures Best Recalls Panko Bread Crumbs for Undeclared Milk

    Natures Best is recalling Panko Style Bread Crumbs due to undeclared milk, a major food allergen.

    Product
    Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1493-2014·2014-02-19

    Natures Best Pancake and Waffle Mix Recalled for Undeclared Milk

    Natures Best is recalling specific lots of Kinnikinnick pancake and waffle mix due to undeclared milk.

    Product
    Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2014·2014-02-19

    Araya Chocolate-Covered Fruits Recalled for Undeclared Allergens

    Araya, Inc. is recalling chocolate-covered dry fruits due to potential undeclared allergens. The products were distributed nationwide.

    Product
    Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14107·2014-02-19

    Lucent Ace Recalls LED Flashlights Due to Burn Hazard

    Lucent Ace Manufacturing is recalling about 3,000 LED flashlights sold at Academy Sports + Outdoors because the battery can short and cause the canister to rupture, posing a burn hazard.

    Product
    LED flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0939-2014·2014-02-19

    RTI Surgical Recalls OPTEFORM Allograft Paste Due to Incorrect Dispenser

    RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.

    Product
    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Resea
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0943-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects

    Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1081-2014·2014-02-19

    Caraco Recalls Oxcarbazepine Tablets Due to Broken Tablets

    Caraco Pharmaceutical Laboratories is recalling 7,005 bottles of Oxcarbazepine 300 mg tablets because some tablets are broken.

    Product
    OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Mixing Cup Arrays

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Mixing Cup Arrays used on VITROS 250 and 350 systems due to an increase in software errors.

    Product
    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0975-2014·2014-02-19

    Stryker Recalls Incorrect Patient-Specific Customized Implant Kit

    Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.

    Product
    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or cr
    Category
    Medical Device
    Distribution
    1 state

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