The Recall Desk

Archive

October 2017 recalls

337 recalls were announced in October 2017.

What the numbers show

Critical
11
Severe
96
High
159
Moderate
58
Low
13

Of the 337 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

Which agencies issued them

301–337 of 337

  • HighFDA (Devices)·Z-3223-2017·2017-10-04

    Teleflex Percuvance Scissors Tool Tip Recall for Connection and Jaw Issues

    Teleflex Medical is recalling Percuvance Scissors Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft ti
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-1176-2017·2017-10-04

    Ketorolac Injection Recalled for Visible Crystalline Particulate

    RemedyRepack Inc. is recalling 40 vials of Ketorolac Trom 30 mg/mL Injection due to visible crystalline particulate.

    Product
    Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Ra
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3216-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2017·2017-10-04

    Teva Recalls Acarbose Tablets Due to Incorrect Expiration Date Labeling

    Teva Pharmaceuticals USA is recalling 3,275 bottles of Acarbose Tablets, 25 mg, because the product labeling displays an incorrect expiration date of July 2018 instead of the correct date of July 2017.

    Product
    Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3214-2017·2017-10-04

    Ultradent Paper Points Recalled for Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.

    Product
    Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3584-2017·2017-10-04

    Frozen Broccoli and Cheese Soup Recalled for Plastic Pieces

    Diversified Foods and Seasonings, Inc. is recalling frozen Homestyle Broccoli and Cheese Soup because customers found pieces of plastic in the product.

    Product
    Homestyle Broccoli and Cheese Soup, 1.66 lb Plastic boil-n-bag pouches, frozen, Contains: Milk, Soy, Wheat
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3209-2017·2017-10-04

    Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.

    Product
    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3215-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3227-2017·2017-10-04

    Medtronic Heli-FX Guide Catheter Recalled for Labeling Mismatch

    Medtronic is recalling 20 units of the Heli-FX Guide 42 mm catheter because the deflection length on the handle does not match the box label.

    Product
    Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3218-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3211-2017·2017-10-04

    Deerfield Imaging Recalls Starburst Adaptor Thumb Screws Due to Incorrect Thread

    Deerfield Imaging is recalling six Starburst adaptor thumb screws because they have incorrect threads. The affected units were distributed in Illinois, Oregon, and Pennsylvania.

    Product
    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3212-2017·2017-10-04

    Teleflex Recalls LMA MADgic Devices Due to Labeling Deficiencies

    Teleflex Medical is recalling LMA MADgic devices because package labels may contain missing or incomplete information.

    Product
    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3217-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3226-2017·2017-10-04

    Bard Magic 3 Antibacterial Catheters Recalled for Missing Coating

    C.R. Bard is recalling specific lots of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheters because they may lack the hydrophilic coating.

    Product
    Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-3213-2017·2017-10-04

    Smiths Medical Recalls UniPerc Tracheostomy Tube Kits with Incorrect Obturator Size

    Smiths Medical is recalling 89 UniPerc tracheostomy tube kits because they contain a 9.0mm obturator instead of the correct 8.0mm size.

    Product
    UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tub
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3210-2017·2017-10-04

    Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.

    Product
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3207-2017·2017-10-04

    Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.

    Product
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3206-2017·2017-10-04

    Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions

    Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.

    Product
    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1179-2017·2017-10-04

    Sandoz Recalls Ampicillin Vials Due to Missing Labels

    Sandoz Inc is recalling 13,435 packs of Ampicillin for Injection because some vials are missing labels. The recall covers distribution in the USA and Puerto Rico.

    Product
    AMPICILLIN — AMPICILLIN (AMPICILLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3204-2017·2017-10-04

    Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.

    Product
    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3208-2017·2017-10-04

    Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions

    Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.

    Product
    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESS
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·17V616000·2017-10-03

    Braun Recalls 2016 BraunAbility MXV Vehicles Due to Airbag Sensor Defect

    Braun is recalling 2016 BraunAbility MXV wheelchair accessible vehicles because a seat position sensor may dislodge, potentially causing the frontal airbag to deploy with improper force.

    Product
    BRAUN — BRAUN BRAUNABILITY MXV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V615000·2017-10-03

    Great Dane Recalls 2018 Everest Trailers Due to Brake Caliper Bolt Issue

    Great Dane is recalling 2018 Everest trailers because brake caliper bolts may not be properly torqued, which could cause the caliper to detach and result in a loss of braking ability.

    Product
    GREAT DANE — GREAT DANE EVEREST SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18001·2017-10-03

    Playtex Recalls Children's Plates and Bowls Due to Choking Hazard

    Playtex is recalling approximately 3.6 million children's plates and bowls because the clear plastic layer can peel off, posing a choking hazard to young children.

    Product
    Children's Playtex plates and bowls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·105-2017·2017-10-03

    H-E-B Recalls Seasoned Diced Chicken Thighs for Undeclared Wheat Allergen

    H-E-B Meat Plant is recalling approximately 1,150 pounds of seasoned diced chicken thighs sold in Texas because the product contains wheat, an undeclared allergen.

    Product
    H-E-B Meat Plant Recalls Poultry Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·17E057000·2017-10-03

    NAPA and Evercraft 800lb Transmission Jacks Recalled for Bolt Failure

    International Specialty Services is recalling NAPA and Evercraft 800lb transmission jacks because a bolt may loosen, causing the saddle to destabilize and the transmission to tip over.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17E058000·2017-10-03

    UD Recalls One Hino Engine for 2008 UD1800 Trucks Due to Wear Risk

    UD Trucks is recalling one Hino engine sold as a replacement for 2008 UD1800 trucks because shifting wrist pin bushings may cause excessive cylinder wear and engine failure.

    Product
    UD — UD UD1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V614000·2017-10-02

    Trail King Recalls 2018 Fifth-Wheel Trailers Due to Brake Caliper Bolt Issue

    Trail King is recalling 2018 Fifth Wheel Live Bottom trailers because improperly torqued brake caliper bolts may allow the caliper to detach, increasing crash risk.

    Product
    TRAIL KING — TRAIL KING FIFTH-WHEEL LIVE BOTTOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E055000·2017-10-02

    IMMI Recalls School Bus Seats Due to Fracturing Buckle Mount Rods

    Indiana Mills and Manufacturing is recalling Generation IV school bus seats because the buckle mount rods may fracture, increasing injury risk in crashes.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E056000·2017-10-02

    Hale Products Recalls Firefighting Water Pump Retaining Rings

    Hale Products is recalling retaining rings for firefighting water pumps that may corrode and fail, reducing water pressure and hindering firefighting efforts.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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