The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

701–766 of 766

  • HighFDA (Food)·F-1825-2016·2016-08-03

    GFS Sea Salt Caramel Cheesecake Recalled for Undeclared Peanut Allergen

    The Father's Table is recalling GFS Sea Salt Caramel Cheesecake because it contains undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    GFS Sea Salt Caramel Cheesecake, 68 oz, 14 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1831-2016·2016-08-03

    Frito-Lay Recalls Fun Times Mix for Potential Undeclared Peanuts

    Frito-Lay is recalling 32-count Fun Times mix packages nationwide due to a potential undeclared peanut ingredient.

    Product
    32 count Fun Times mix packaged as 32 single flexible plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1834-2016·2016-08-03

    Casey's Bakery Almond Patties Recalled for Undeclared Milk Allergen

    Casey's Bakery is recalling Almond Patties because the product contains butter but fails to declare the milk allergen.

    Product
    Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2290-2016·2016-08-03

    Sunrise Medical Recalls Quickie Q7 Wheelchairs Due to Backrest Bracket Failure

    Sunrise Medical is recalling Quickie Q7 wheelchairs because the backrest bracket can fracture, causing the backrest to detach from the chair frame.

    Product
    Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2261-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1810-2016·2016-08-03

    CRF Frozen Foods Recalls Green Beans for Listeria Risk

    CRF Frozen Foods is recalling various brands of frozen green beans due to potential Listeria monocytogenes contamination. The products were distributed in the US, Canada, and Japan.

    Product
    Cut Green Beans, Brand Bybee Foods, Net Wt 50 lb, UPC 205050004485CR Organic Petite Whole Green Beans, Brand Bybee Foods, Net Wt 5 lb, UPC 5711000146 1" Cut Green Beans, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800012 Whole Green Beans, Brand Bybee's Best, Net Wt 15 lb, UPC 4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2016·2016-08-03

    Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk

    Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.

    Product
    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1829-2106·2016-08-03

    Frito-Lay Recalls Baked & Popped Mix for Potential Undeclared Peanuts

    Frito-Lay is recalling 20-count Baked & Popped Mix packages nationwide due to a potential undeclared peanut allergen.

    Product
    20 count Baked & Popped Mix packaged as 20 single flexible plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1827-2016·2016-08-03

    Rold Gold Pretzels Recalled for Potential Undeclared Peanuts

    Frito-Lay is recalling specific Rold Gold pretzel products due to the potential presence of undeclared peanuts.

    Product
    Rold Gold Tiny Twists 1 oz., 2 oz., 16 oz., and 20 1/2 oz.; Rold Gold Original Pretzel Thins 4 oz. and 16 oz.; Rold Gold Sticks 16 oz. packaged in flexible plastic bags.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2016·2016-08-03

    Beckman Coulter Allegra X-5 Rotor Yoke Recalled for Defect

    Beckman Coulter is recalling Allegra X-5 rotor yokes because a defect allows improper rotor seating, which could lead to rotor failure if buckets are loaded in an imbalanced configuration.

    Product
    Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2016·2016-08-03

    Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect

    Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.

    Product
    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general pur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2016·2016-08-03

    Ortho-Clinical VITROS Calcium Slides Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.

    Product
    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling container fill and transfer sets because they cannot meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
    Category
    Medical Device
    Distribution
    21 states
  • HighCPSC·16238·2016-08-03

    Porta Recalls Residential Elevators with Plastic Door Locks

    Porta Inc. is recalling about 60,000 residential elevators because plastic door locks may fail, allowing doors to open before the car arrives and posing a fall hazard.

    Product
    Residential elevators with electro mechanical door locks (EMDLs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1821-2016·2016-08-03

    GFS Creamy Indulgence Cheesecake Recalled for Undeclared Peanut Allergen

    The Father's Table is recalling GFS Creamy Indulgence NY Style Cheesecake because it contains undeclared peanut protein.

    Product
    GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers. Manufactured by The Fathers Table and Distributed by Gordon Food Service.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1846-2016·2016-08-03

    Armour Snackmaker Keebler Animals Crackers Recalled for Peanut Residue

    Armour Eckrich Meats LLC is recalling Armour Snackmaker Keebler Animals Crackers due to potential low levels of peanut residue from a supplier ingredient.

    Product
    Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial Flavors, Plain Icing which are packaged in 2.7oz packages; Unit UPC code 2781500240 . There are 18 packages to a case, Case SKU 2781500240. The responsible firm name on the label is Armour-Ec
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2279-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Smal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2298-2016·2016-08-03

    Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.

    Product
    Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2280-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2297-2016·2016-08-03

    Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error

    Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.

    Product
    SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a resul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2263-2016·2016-08-03

    Metrix Dual Chamber Container Recall Due to Dispensing Accuracy Issues

    The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.

    Product
    Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2277-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introdu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2016·2016-08-03

    Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.

    Product
    Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2016·2016-08-03

    LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling

    LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2264-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, 250 mL and 500 mL, . .
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-1448-2016·2016-08-03

    Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2262-2016·2016-08-03

    Metrix Dual Chamber Container Fill and Transfer Sets Recalled for Accuracy Issues

    The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.

    Product
    Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2276-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.

    Product
    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1449-2016·2016-08-03

    Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications

    Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.

    Product
    Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2251-2016·2016-08-03

    Best Theratronics Cabinet X-Ray Systems Recalled for Performance Non-Compliance

    Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.

    Product
    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2016·2016-08-03

    LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.

    Product
    AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2299-2016·2016-08-03

    Siemens Recalls Theophylline Reagent Due to Increased Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.

    Product
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Food)·F-1848-2016·2016-08-03

    SCD Probiotics Recalls Xtra Immunity Brown Rice Antioxidant Probiotic Extract

    Sustainable Community Development LLC is recalling Xtra Immunity Brown Rice Antioxidant Probiotic Extract because the dietary supplement contains drug claims, making it misbranded.

    Product
    Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle. UPC 184368000114. The responsible firm name on the label is SCD Probiotics, Kansas City, MO 64106.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2287-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2272-2016·2016-08-03

    Beckman Coulter Recalls UniCel DxC Synchron Systems Due to Leaking Solution

    Beckman Coulter is recalling UniCel DxC Synchron Clinical Systems because the No Foam Bottle Assembly may leak solution.

    Product
    UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hyd
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2288-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2271-2016·2016-08-03

    Alere Signify Mono Test Recalled for Incorrect Labeling Information

    Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2266-2016·2016-08-03

    Alere Mono Rapid Test Recalled for Incorrect Labeling Information

    Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2268-2016·2016-08-03

    Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error

    Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2265-2016·2016-08-03

    Alere Acceava Mono II Rapid Test Strip Labeling Recall

    Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2270-2016·2016-08-03

    Alere San Diego Recalls Stanbio Rely Mono Rapid Test for Labeling Error

    Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2282-2016·2016-08-03

    Tosoh Bioscience Recalls Progesterone 3 Calibrator Sets Due to Incorrect IFU Lot Number

    Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.

    Product
    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2267-2016·2016-08-03

    Alere Clearview MONO Test Recalled for Incorrect Labeling

    Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2269-2016·2016-08-03

    Alere Proadvantage Mono Rapid Test Cassette Recalled for Labeling Error

    Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1451-2016·2016-08-03

    Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels

    Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V572000·2016-08-02

    Aluma/KLM Recalls 2011-2015 Trailers Due to Missing Welds

    Aluma/KLM is recalling 2011-2015 5410T and 5410WD trailers because missing welds may cause the tongue to separate, increasing crash risk.

    Product
    ALUMA KLM — ALUMA KLM 5410T, 5410WD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V574000·2016-08-02

    Hyundai Recalls 2013 Elantra Vehicles for Brake Pedal Stopper Pad Defect

    Hyundai is recalling 64,500 2013 Elantra vehicles because a deteriorating brake pedal stopper pad can prevent the brake light switch from retracting, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V571000·2016-08-02

    Thor Motor Coach Recalls Motorhomes Due to Flammable Shower Curtains

    Thor Motor Coach is recalling specific 2012-2017 motorhomes because the shower curtains may not resist catching fire, increasing injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH ACE, ROAD BEAR RENTAL, CITATION, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16236·2016-08-02

    Starbucks Recalls Stainless Steel Straws Due to Mouth Laceration Risk

    Starbucks is recalling approximately 2.5 million stainless steel straws sold in the U.S. because the rigid design poses a risk of mouth lacerations to young children.

    Product
    Stainless Steel Straws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16237·2016-08-02

    BYA Sports Recalls Double Hammocks Due to Fall Hazard

    BYA Sports is recalling approximately 760 double hammocks because a weld on the metal ring can fail, causing the hammock to fall and posing a fall hazard to users.

    Product
    Bring Your Adventure (BYA) Sports hammocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·059-2016 EXP·2016-08-01

    Michael Angelo's Recalls Frozen Shrimp Scampi and Meat Lasagna for Allergens

    Michael Angelo's Gourmet Foods is recalling 5,677 pounds of frozen shrimp scampi and meat lasagna due to misbranding and undeclared allergens like chicken, egg, soy, and shrimp.

    Product
    Michael Angelo's Gourmet Foods Inc. — Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi and Meat Lasagna Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V566000·2016-08-01

    Heartland Recalls Travel Trailers Due to Fire Risk from LED Light

    Heartland is recalling specific 2015-2017 travel trailers and fifth wheels because an LED light may short circuit and overheat, increasing fire risk.

    Product
    HEARTLAND — HEARTLAND MALLARD, ELKRIDGE, SUNDANCE, WILDERNESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V567000·2016-08-01

    E-One Recalls 2015-2016 Cyclone II and Typhoon Fire Trucks

    E-One is recalling 2015-2016 Cyclone II and Typhoon fire trucks because a transmission component may fail, preventing the vehicle from pumping water to fight fires.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V569000·2016-08-01

    KME Fire Trucks Recalled for Transmission Power Switching Defect

    KME is recalling 112 fire trucks because a transmission component may fail, preventing operators from switching power output needed for firefighting.

    Product
    KME — KME PREDATOR SS, PREDATOR, PREDATOR PANTHER
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.