The Recall Desk

Archive

September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical
91
Severe
189
High
306
Moderate
125
Low
23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 26% are Severe.

Which agencies issued them

701–734 of 734

  • HighFDA (Devices)·Z-2669-2016·2016-09-07

    Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk

    Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2016·2016-09-07

    Medical Vision Ab Recalls Double Pump RF Patient Cassettes

    Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.

    Product
    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Food)·F-1991-2016·2016-09-07

    Tippin's Key Lime Pie Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 8-inch Key Lime Pies because an ingredient may contain low levels of peanut residue.

    Product
    Tippins 8" Key Lime Pie packaged in aluminum pie plates with plastic covers. The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106. UPC code is 680816050057. Packaged in 8 pies per case. Shipped frozen.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1474-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2016·2016-09-07

    Terumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling

    Terumo is recalling 2,207 cardiovascular procedure kits because they are labeled as containing coated tubing but actually contain non-coated tubing.

    Product
    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2005-2016·2016-09-07

    Natrium Products Recalls Sodium Bicarbonate Due to Lubricating Oil Contamination

    Natrium Products Inc. is recalling 1,677 bags of sodium bicarbonate that may contain varying amounts of food-grade lubricating oil.

    Product
    SODIUM BICARBONATE, CAS # 144-55-8, USP/FCC GRADE 1, NET WEIGHT 50 lbs./22.68 kg --- Natrium Products, Inc. 58 Pendleton Street, Cortland, NY 13045
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2685-2016·2016-09-07

    Merge Healthcare Recalls RadSuite Software Due to Image Display Errors

    Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1475-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2016·2016-09-07

    Fujifilm Digital Mammography System Recalled for Biopsy Workflow Error

    Fujifilm is recalling two Aspire HD Digital Mammography Systems because an aborted stereo biopsy may cause an error that prevents the system from operating properly.

    Product
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1477-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1478-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2016·2016-09-07

    Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature

    Nidek Inc is recalling 29 Specular Microscope CEM-530 units because software versions 1.08 and 1.09 include an unapproved analysis feature.

    Product
    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2686-2016·2016-09-07

    Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

    Product
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2707-2016·2016-09-07

    Limacorporate SMR Allen Wrench Recalled for Dimensional Non-Conformance

    Limacorporate S.p.A is recalling 76 SMR allen wrenches (5 mm) because they are dimensionally non-conforming and may not function with some T-handles.

    Product
    SMR allen wrench 5 mm, product code 9013.50.210
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1473-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1476-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V640000·2016-09-06

    Acura Recalls 2015 TLX Vehicles for Transmission Wire Harness Defect

    Honda is recalling 2015 Acura TLX vehicles because transmission wire harness connections may have insufficient crimps, causing the vehicle to unexpectedly shift to neutral and increasing crash risk.

    Product
    ACURA — ACURA TLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V641000·2016-09-06

    Audi Recalls 2017 Q7 Vehicles for Third-Row Seat Back Defect

    Volkswagen Group of America is recalling 2017 Audi Q7 vehicles because the third-row seat back may move forward in a crash, increasing injury risk.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V643000·2016-09-06

    Ford Recalls Multiple Models Due to Door Latch Defect

    Ford is recalling specific 2012-2016 vehicles because door latches may break, allowing doors to open while driving.

    Product
    FORD — FORD, LINCOLN MUSTANG, ESCAPE, TRANSIT CONNECT, MKC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V644000·2016-09-06

    Mazda Recalls Vehicles Due to Corroded Lift Gate Support Struts

    Mazda is recalling specific 2010-2016 models because lift gate support struts may corrode and break, causing the gate to drop unexpectedly and injure users.

    Product
    MAZDA — MAZDA MAZDASPEED3, MAZDA3, MAZDA5, CX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V642000·2016-09-06

    Audi Recalls Vehicles Due to Inoperative Side Marker Lights

    Volkswagen Group of America is recalling certain Audi models because software may cause side marker lights to fail, reducing visibility at night.

    Product
    AUDI — AUDI A4 ALLROAD, TT ROADSTER, A3 CABRIOLET, Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V636000·2016-09-02

    Nissan Recalls Maxima and Murano Models Due to Brake Fluid Leak Fire Risk

    Nissan is recalling certain 2015-2017 Maxima and Murano vehicles because brake fluid may leak onto an electrical circuit board, increasing the risk of a fire.

    Product
    NISSAN — NISSAN MAXIMA, MURANO HYBRID, MURANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V638000·2016-09-02

    Tiffin Recalls 2017 Allegro Bus Motorhomes Due to Mirror Defect

    Tiffin is recalling 2017 Allegro Bus motorhomes because the passenger side mirror may move while driving, reducing visibility and increasing crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16772·2016-09-02

    John Deere Recalls Backhoe Attachments Due to Crushing Hazard

    John Deere is recalling about 50 model 485A backhoe attachments because mounting hardware could loosen, causing the frame to rotate and crush the operator.

    Product
    Backhoe attachments for compact utility tractors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V635000·2016-09-01

    Kaufman Recalls 2015-2016 Mini Car Haulers Due to Suspension Defect

    Kaufman Trailers is recalling 285 model year 2015-2016 Mini 5-Car Haulers because a suspension spring eye may break, allowing the axle to slide and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN MINI CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16257·2016-09-01

    Polaris Recalls RZR XP Turbo Vehicles Due to Fire and Burn Hazards

    Polaris is recalling approximately 13,000 RZR XP Turbo recreational off-highway vehicles because engine overheating and loose drain tubes can cause fires and severe burn injuries.

    Product
    Recreational Off-Highway Vehicles (ROVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16T013000·2016-09-01

    Goodyear Recalls G399A LHS Tires Due to Tread Separation Risk

    Goodyear is recalling specific G399A LHS tires due to a manufacturing defect that may cause tread separation, increasing the risk of a crash.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16256·2016-09-01

    SAHN Designs Recalls Bicycle Helmets Due to Head Injury Risk

    SAHN Designs is recalling SAHN Classic SH523 bicycle helmets because they do not meet federal impact safety standards, posing a risk of head injury.

    Product
    SAHN Classic bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·076-2016·2016-09-01

    Atherstone Foods Recalls Chicken Wraps Due to Undeclared Soy Allergen

    Atherstone Foods is recalling approximately 422 pounds of chicken wrap products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Glass Onion Catering — Atherstone Foods Recalls Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state

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