The Recall Desk

Archive

December 2015 recalls

614 recalls were announced in December 2015.

What the numbers show

Critical
17
Severe
215
High
208
Moderate
133
Low
41

Of the 614 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

601–614 of 614

  • ModerateFDA (Devices)·Z-0330-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2016·2015-12-02

    Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools

    Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.

    Product
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0329-2016·2015-12-02

    Palindrome Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2016·2015-12-02

    Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

    Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

    Product
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2016·2015-12-02

    Siemens Syngo Imaging Software Recall for Version VB36D_HF02

    Siemens Medical Solutions is recalling three units of Syngo Imaging software to provide supplementary information regarding the release of Version VB36D_HF02.

    Product
    Syngo Imaging VB36D_HF02. Radiological image processing system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0266-2016·2015-12-02

    Curley Parsley Recalled for Pesticide Contamination

    MR Cuta dba Riley's is recalling Curley Parsley because it tested positive for the pesticides propanocarb and trifloxystrobin.

    Product
    Curley Parsley 4/5 lb packaged in cardboard box, UPC code 740695801109
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-0322-2016·2015-12-02

    Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling

    Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.

    Product
    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0328-2016·2015-12-02

    Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies

    Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.

    Product
    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2016·2015-12-02

    Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert

    Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.

    Product
    2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    27 states
  • HighNHTSA·15V808000·2015-12-01

    Newmar Recalls Motorhomes Due to Refrigerator Door Latch Defect

    Newmar is recalling specific motorhomes because refrigerator door latches may lock without the operator's knowledge, posing a risk of injury if a person is trapped inside.

    Product
    NEWMAR — NEWMAR VENTANA, VENTANA LE, CANYON STAR, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V810000·2015-12-01

    Altec Recalls 2011-2015 Brush Chippers Due to Weld Defects

    Altec is recalling 2011-2015 DSC6 and DC610 brush chippers because improper welds or incorrect spacers may cause the anvil to detach, posing an injury risk.

    Product
    ALTEC — ALTEC DSC6 BRUSH CHIPPER, DC610 BRUSH CHIPPER
    Category
    Consumer Product
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2015.