The Recall Desk

Archive

May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical
44
Severe
214
High
219
Moderate
255
Low
39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 28% are Severe.

501–600 of 771

  • ModerateFDA (Devices)·Z-1904-2017·2017-05-10

    Breg Inc Recalls Knee Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Knee L/XL Dressings because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1978-2017·2017-05-10

    Anspach Effort Recalls 26.65cm Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 16 units of the 26.65cm Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    26.65CM ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2017·2017-05-10

    Anspach Effort eMax2 Plus Console Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.

    Product
    Console, eMax2 Plus Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2181-2017·2017-05-10

    Tropicana Orange Juice Recalled for Potential Plastic Fragments

    Quaker Oats Co is recalling one lot of Tropicana orange juice because it may contain small plastic fragments.

    Product
    Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) 7L), UPC 48500 75823, Tropicana Manufacturing Company, Inc., Bradenton, Florida 34206 USA
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1982-2017·2017-05-10

    Anspach Effort 5.9CM Pneumatic Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 49 units of the 5.9CM Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.

    Product
    5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2017·2017-05-10

    Anspach Effort Recalls 14cm QD Angle Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 14cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    14cm QD Angle Attachment Product Usage: Product attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2020-2017·2017-05-10

    Anspach Effort Recalls 11cm QD Angle Attachments for Pneumatic Systems

    The Anspach Effort, Inc. is recalling 455 units of 11cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    11cm QD Angle Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1906-2017·2017-05-10

    Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads

    Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1974-2017·2017-05-10

    Anspach Effort Recalls 14CM Angle Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 17 units of the 14CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    14CM ANGLE ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2017·2017-05-10

    Terumo Destination Renal Guiding Sheath Recalled for Missing Coating

    Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.

    Product
    Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2017·2017-05-10

    Perouse Medical Recalls Dolphin Inflation Devices Due to Broken Blister

    Perouse Medical is recalling 18,431 Dolphin Inflation Devices because of complaints regarding broken blisters. The devices were distributed in Arizona, Minnesota, and Tennessee.

    Product
    DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2164-2017·2017-05-10

    Goya Octopus in Pickled Sauce Recalled for Squid Mislabeling

    Tradewind Foods is recalling Goya Octopus in Pickled Sauce because the product contains squid instead of octopus, as labeled.

    Product
    Goya Octopus in Pickled Sauce, Pulpo a la Marinera, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0694-2017·2017-05-10

    P & L Development Recalls Subpotent Diphenhydramine HCl Allergy Softgels

    P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.

    Product
    Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2017·2017-05-10

    Anspach Effort 16cm Minimally Invasive Attachment Pneumatic System Recall

    The Anspach Effort, Inc. is recalling 177 units of the 16cm Minimally Invasive Attachment because the supplied directions for use did not contain a recommended service interval.

    Product
    16cm Minimally Invasive Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2017·2017-05-10

    Anspach Effort Recalls Autolube-III Pneumatic Systems for Missing Service Interval

    The Anspach Effort, Inc. is recalling 17 Autolube-III pneumatic systems because the supplied directions for use did not include a recommended service interval.

    Product
    Autolube-III with Foot Guard Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1999-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 11.0cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    11.0cm Long Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Stability Issues

    Smith & Nephew is recalling 2017 units of Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1938-2017·2017-05-10

    Anspach Effort Recalls Autolube-III Pneumatic System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 51 units of the Autolube-III with Irrigation pneumatic system because the supplied directions for use did not contain a recommended service interval.

    Product
    Autolube-III with Irrigation Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 8.0cm Medium Pneumatic System Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    8.0cm Medium Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2017·2017-05-10

    Anspach Effort Minimal Access Attachment Pneumatic System Recall

    The Anspach Effort, Inc. is recalling 618 Minimal Access Attachment pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    Minimal Access Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2017·2017-05-10

    Anspach Effort 6.5cm Adult Cranial Thin Foot Plate Recall

    The Anspach Effort, Inc. is recalling 130 units of 6.5cm Adult Cranial Thin Foot Plates because the supplied directions for use did not contain a recommended service interval.

    Product
    6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2017·2017-05-10

    Amneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.

    Product
    Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Stability Data

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2016-2017·2017-05-10

    Anspach Effort Recalls Otologic Curved Micro Pneumatic Systems

    The Anspach Effort, Inc. is recalling 119 Otologic Curved Micro pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    Otologic Curved Micro Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2017·2017-05-10

    Fluconazole Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2002-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 247 pneumatic system attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    10.5cm Long Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2017·2017-05-10

    Anspach Effort Oscillating Micro-Saw Pneumatic System Recall

    The Anspach Effort, Inc. is recalling 16 Oscillating MICRO-SAW pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    Oscillating MICRO-SAW Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1932-2017·2017-05-10

    Anspach Effort AL-III Pneumatic Hose Recall for Missing Service Interval

    The Anspach Effort, Inc. is recalling 17 AL-III pneumatic hose units because the supplied directions for use did not contain a recommended service interval.

    Product
    AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,126 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2017·2017-05-10

    Beckman Coulter AQUIOS CL Flow Cytometer Software Export Defect Recall

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the software's Export feature incorrectly handles Tetra Combo CRD files.

    Product
    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2017·2017-05-10

    Breg Inc Recalls Dressing Back P/N 09810 Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Back P/N 09810 because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2017·2017-05-10

    Anspach Effort 45 Degree Contra Angle Attachment Recall for Missing Service Interval

    The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    45 degree Contra Angle Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2013-2017·2017-05-10

    Anspach Effort Pneumatic Attachment Recalled for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 8.0CM Heavy Duty Medium Pneumatic Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1948-2017·2017-05-10

    Anspach Electronic Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 209 Electronic Foot Controls with Direction Switches because the supplied directions for use did not contain a recommended service interval.

    Product
    Electronic Foot Control with Direction Switch Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2017·2017-05-10

    Anspach Effort Recalls Jacobs Chuck Attachment Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 50 units of the SMALL ATTACHMENT, JACOBS CHUCK because the supplied directions for use did not contain a recommended service interval.

    Product
    SMALL ATTACHMENT, JACOBS CHUCK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1922-2017·2017-05-10

    Boston Scientific Recalls Mislabeled JETSTREAM Atherectomy Catheters

    Boston Scientific is voluntarily removing three lots of JETSTREAM atherectomy catheters because some units were mislabeled with incorrect sizes.

    Product
    The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1919-2017·2017-05-10

    Smith & Nephew Recalls Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,741 units of Renovation osteotome blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2004-2017·2017-05-10

    Anspach Effort Bearing Sleeve Recall for Missing Service Interval

    The Anspach Effort, Inc. is recalling 112 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2017·2017-05-10

    Anspach Effort AL-III Pneumatic System Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 19 AL-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2017·2017-05-10

    Anspach Effort Recalls 9.4cm Micro Revision Attach for Missing Service Interval

    The Anspach Effort, Inc. is recalling 11 units of the 9.4cm Micro Revision Attach, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    9.4CM MICRO REVISION ATTACH, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1945-2017·2017-05-10

    Anspach Effort Recalls XMAX Motor High Strength Hose for Missing Service Interval

    The Anspach Effort, Inc. is recalling 22 XMAX Motor High Strength Hoses because the supplied directions for use did not contain a recommended service interval.

    Product
    XMAX Motor, High Strength Hose Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2017·2017-05-10

    Anspach Effort B-Sagittal Assembly Pneumatic System Recall

    The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2017·2017-05-10

    Richard-Allan Scientific Recalls Shandon Rapid Chrome Kwik-Diff Kits

    Richard-Allan Scientific is recalling Shandon Rapid Chrome Kwik-Diff Kits because the Methylene Blue Solution #3 was mislabeled and actually contained Crystal Violet.

    Product
    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2007-2017·2017-05-10

    Anspach Effort Bearing Sleeve Recalled for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 121 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,416 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2017·2017-05-10

    Anspach Effort Recalls 11CM Angle Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 45 units of the 11CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    11CM ANGLE ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2017·2017-05-10

    Anspach Effort 8.2cm Pneumatic Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 80 units of the 8.2cm Black Max pneumatic attachment because the supplied directions for use did not include a recommended service interval.

    Product
    8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2017·2017-05-10

    Anspach Effort Recalls XMAX Pneumatic Drill System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 554 XMAX Pneumatic Drill Systems because the supplied directions for use did not include a recommended service interval.

    Product
    XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2017·2017-05-10

    Smith & Nephew Recalls Renovation Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Renovation osteotome blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0688-2017·2017-05-10

    Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution

    The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2178-2017·2017-05-10

    Source Naturals Vitamin D-3 Recalled for Lower Concentrations

    Threshold Enterprises Ltd is recalling specific lots of Source Naturals Vitamin D-3 dietary supplements because testing found lower concentrations than labeled.

    Product
    Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1954-2017·2017-05-10

    Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 22 SC2100 foot controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Foot Control without Switches, SC2100 Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2017·2017-05-10

    Anspach Effort Bearing Sleeve Recall for Missing Service Interval

    The Anspach Effort, Inc. is recalling 58 Bearing Sleeve units because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Stability Data

    Smith & Nephew is recalling specific lots of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2159-2017·2017-05-10

    Frozen Shrimp Recalled for Failure to Declare Sulfites

    Global Marketing Enterprises is recalling 1,173.19 lbs of frozen farm-raised head-on shrimps because the label does not declare the presence of sulfites.

    Product
    40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep Frozen, Must be fully cooked before serving. 1.02 kg, 2.24 lb. Packed by: Global Marketing Ent Inc, Chicago, IL 60616
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0696-2017·2017-05-10

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failures

    Akorn Inc is recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension because the product failed to meet dissolution specifications.

    Product
    Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2000-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 10.5cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1940-2017·2017-05-10

    Anspach Effort Recalls 19cm Pneumatic Attachment Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 41 units of the 19cm Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.

    Product
    19cm Attachment, Black Max Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2017·2017-05-10

    Anspach Effort 7.2cm Adjustable Drill Guide Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 198 units of the 7.2cm Adjustable Drill Guide because the supplied directions for use did not contain a recommended service interval.

    Product
    7.2cm Adjustable Drill Guide Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2010-2017·2017-05-10

    Anspach Effort Recalls Minimal Access Attachments for Missing Service Interval

    The Anspach Effort, Inc. is recalling 22 Minimal Access Attachments because the supplied directions for use did not contain a recommended service interval.

    Product
    Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches

    Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2017·2017-05-10

    Anspach Effort Recalls Heavy Duty Long Heavy Short Attachment

    The Anspach Effort, Inc. is recalling 206 units of the 20.2cm Heavy Duty Long Heavy Short Attachment because the supplied directions for use did not contain a recommended service interval.

    Product
    20.2cm Heavy Duty Long Heavy Short Attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2017·2017-05-10

    Anspach Effort Recalls Adjustable Drill Guide for Missing Service Interval

    The Anspach Effort, Inc. is recalling six units of the Adjustable Drill Guide, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    ADJUSTABLE DRILL GUIDE, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide

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