The Recall Desk

Archive

April 2016 recalls

764 recalls were announced in April 2016.

What the numbers show

Critical
20
Severe
134
High
348
Moderate
206
Low
56

Of the 764 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

701–764 of 764

  • HighFDA (Devices)·Z-1255-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1287-2016·2016-04-06

    Ossur Recalls NecLoc Extrication Collars and Other Medical Devices

    Ossur Americas is recalling NecLoc Extrication Collars and other medical devices due to a defect described as 'the p'.

    Product
    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1307-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E029000·2016-04-06

    Hale Portable Pumps Recalled for Mislabeled Warning Light

    Hale Products Inc. is recalling portable pumps with Yanmar diesel engines due to a mislabeled dashboard warning light that could hinder fire suppression.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Back Support Suspenders

    Ossur Americas is recalling various medical devices, including back support suspenders, due to a defect described in the source text.

    Product
    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1289-2016·2016-04-06

    Ossur Recalls Rebound Cartilage Knee Braces and Other Medical Devices

    Ossur Americas is recalling Rebound Cartilage knee braces and other medical devices due to a defect described in the source text.

    Product
    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1310-2016·2016-04-06

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Leak

    Siemens is recalling 1,757 AXIOM Artis angiography systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0798-2016·2016-04-06

    Walter's Pharmacy Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Tobramycin 14 mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects 10 mL bottles distributed in Pennsylvania.

    Product
    Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0811-2016·2016-04-06

    Nestle Trio Low Sodium Brown Gravy Recalled for Metal Fragments

    Nestle USA is recalling Trio Low Sodium Brown Gravy because an ingredient may contain metal fragments.

    Product
    Trio¿ Low Sodium Brown Gravy, 16 ounce, flexible pouch, NET WT 16 OZ CONTAINS: MILK, SOY, WHEAT, INGREDIENTS MAY CONTAIN EGGS DISTRIBUTED BY: NESTLE PROFESSIONAL NORTH AMERICA SOLON, OH 44139
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1006-2016·2016-04-06

    NatureMed Recalls All Day Energy Greens Powdered Drink

    NatureMed Inc. is recalling All Day Energy Greens powdered drink due to reported cases of gastrointestinal distress.

    Product
    All Day Energy Greens Fruity (ADEGF), Great Fruity Taste!, Net Wt 10.5 oz (299g), UPC Code 893320002096 and 893320002423.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1291-2016·2016-04-06

    Ossur Recalls Rebound Air Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Air Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1295-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including the Unloader Custom Lite, due to a defect described in the source text.

    Product
    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1306-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2016·2016-04-06

    ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk

    ICU Medical is recalling specific IV administration sets with ChemoLock ports because the connection may develop a leak.

    Product
    30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0998-2016·2016-04-06

    ProSupps Dr. Jekyll Pre-Workout Recalled for Potential Picamilon Content

    ProSupps USA LLC is recalling Dr. Jekyll Intense Pump Pre Workout because it may contain the non-dietary ingredient Picamilon.

    Product
    Prosupps Dr. Jekyll, INTENSE PUMP PRE WORKOUT, 30 SERVINGS, FRUIT PUNCH NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.4 OZ (324 GRAMS) packaged in red plastic jars with black lids.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.

    Product
    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0819-2016·2016-04-06

    Delphi Greek Pepperoncini Recalled for Undeclared Sulfites

    Constantine Poulos and Company is recalling Delphi Greek Pepperoncini due to undeclared sulfites. The product was distributed in five states prior to February 11, 2016.

    Product
    DELPHI GREEK PEPPERONCINI; Peppers, Water, Salt, Vinegar, Citric Acid, Sodium Benzoate. INTERNATIONAL FOODS, INC. BURLINGTON, VT 05401 NET Weight 3 lb. 8 oz. Product is stored at ambient temperature.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1278-2016·2016-04-06

    Siemens Recalls Cios Alpha Mobile X-Ray Systems Due to Software Issues

    Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.

    Product
    Cios Alpha, mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2016·2016-04-06

    Siemens Recalls Cios Alpha X-Ray Systems Due to Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because a defective part could increase the risk of electrical shock for service personnel during maintenance.

    Product
    CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Miami J Collars

    Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.

    Product
    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1257-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.

    Product
    110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1297-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-1271-2016·2016-04-06

    Medtronic Ascenda Intrathecal Catheter Kit Recalled for Labeling Errors

    Medtronic is voluntarily removing a single Ascenda Intrathecal Catheter kit due to incorrect outer package labels that may result in missing components.

    Product
    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1280-2016·2016-04-06

    Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect

    Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0812-2016·2016-04-06

    Ventura Foods Recalls 35 lb. Liquid Fry Shortening Due to Plastic Contamination

    Ventura Foods is recalling various brands of 35 lb. liquid fry shortening because plastic from the jugs may have entered the product.

    Product
    45532-ATL : Atlantic Food Distributors Premium Clear Liquid Fry Shortening 35 lb. ; 45531-ATL : Atlantic Food Distributors Premium Creamy Liquid Fry Shortening 35 lb. ; 45531-CHP : Chef's Pride Creamy Liquid Fry Shortening 35 lb. ; 45531-UBA : Creamy Liquid Fry Shortening 35…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1007-2016·2016-04-06

    Ruiz Food Products Recalls Cheesy Pepper Jack Tortilla Wraps Due to Plastic

    Ruiz Food Products Inc is recalling 10,261 cases of Cheesy Pepper Jack Wrapped In A Battered Flour Tortilla because plastic was found in the product by a customer.

    Product
    Cheesy Pepper Jack Wrapped In A Battered Flour Tortilla For Institutional Use Only. Net Weight 4.5 lb 2 kg packaged in a cardboard box with black inkjet printing.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1249-2016·2016-04-06

    Medtronic Recalls Reveal LINQ Cardiac Monitor Due to Algorithm Sensitivity Issue

    Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.

    Product
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1267-2016·2016-04-06

    Implant Direct Sybron Recalls GoDirect Dental Implants Due to Tool Error

    Implant Direct Sybron is recalling GoDirect Implants because some consignees received the wrong tool to drive the implant to bone level.

    Product
    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2016·2016-04-06

    Siemens Artis zee/zeego X-Ray Systems Recalled for Cooling System Leak

    Siemens is recalling 1,757 Artis zee/zeego angiographic X-ray systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0999-2016·2016-04-06

    ProSupps Recalls Mr. Hyde Pre-Workout for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling Mr. Hyde Intense Energy Pre-Workout supplements because they may contain the undeclared non-dietary ingredient Picamilon.

    Product
    Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS ORANGE BURST NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 4.0 OZ (113 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS ORANGE BURST NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0813-2016·2016-04-06

    Ventura Foods Recalls Cooking Oil Jugs Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of cooking oil because plastic fragments may be present due to a manufacturing defect in the jugs.

    Product
    45532-CHP: Chef's Pride Soybean Clear Fry Oil 35 lb.; 54135-CHP: Chef's Pride Soybean Salad Oil 35 lb.; 45635-CHP: Chef's Pride Soybean Pan & Grill Frying Oil 35 lb.; 54135-TXR: Texas Roadhouse Soybean Salad Oil 35 lb.; 54135-PAD: Panda Express Soybean Salad Oil 35 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2016·2016-04-06

    Siemens E.CAM Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.

    Product
    The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2016·2016-04-06

    Biomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle

    Biomet Spine is recalling specific Solitaire Ti Spacers because they are mislabeled as having a 12-degree lordotic angle when the actual angle is 6 degrees.

    Product
    10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2016·2016-04-06

    Siemens Artis One X-Ray System Recalled for Data Mirroring Error

    Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.

    Product
    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1263-2016·2016-04-06

    Siemens Symbia Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.

    Product
    The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0782-2016·2016-04-06

    Praxair Recalls 127 Cylinders of Compressed Medical Air Due to Odor

    Praxair Inc. is recalling 127 cylinders of compressed medical air because a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0814-2016·2016-04-06

    Ventura Foods Recalls Canola Frying Oil Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of canola frying oil because plastic from the jug's sealing surface may have been pushed into the product during manufacturing.

    Product
    18159-BLN : Brilliance Clear Zero Premium Clear Canola Frying Oil 35 lb. ; 58503-CHP : Chef's Pride Canola Clear Fry Oil 35 lb. ; 58503-FLV : Flavorite Canola Clear Fry Oil 35 lb. ; 58503-PLF : Planet Fry Canola Clear Fry Oil 35 lb. ; 58503-NGT : Nugget Brand Canola Clear…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2016·2016-04-06

    Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

    Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1001-2016·2016-04-06

    ProSupps Recalls Mr. Hyde Pre-Workout for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling 33 units of Mr. Hyde Intense Energy Pre-Workout because the product may contain undeclared Picamilon.

    Product
    Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS BLUERAZZ NATURAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 3.7 OZ (105 GRAMS) packaged in red plastic jars with black lids.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2016·2016-04-06

    Molteno3 Glaucoma Implants Recalled for Updated Instructions

    Innovative Ophthalmic Products is recalling Molteno3 Glaucoma Implants because the package insert was updated to add a caution statement to minimize off-label use.

    Product
    Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2016·2016-04-06

    Beckman Coulter Recalls MicroScan LabPro Software Due to Editing Error

    Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.

    Product
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1268-2016·2016-04-06

    Pelton & Crane Recalls Helios Track Mounted Dental Lights

    Pelton & Crane is recalling 156 Helios HL3T and HLT track mounted dental lights because they were missing two set screws during initial installation.

    Product
    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2016·2016-04-06

    Wfr/aquaplast Recalls Prone Breast Treatment Tables Due to Scale Misalignment

    Wfr/aquaplast Corp is recalling 30 prone breast treatment tables and devices because some may have misaligned scales, potentially causing orientation differences.

    Product
    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0785-2016·2016-04-06

    Safecor Health Recalls Donnatal Elixir Due to Labeling Error

    Safecor Health is recalling 23 cups of Donnatal Elixir because the label incorrectly lists the dose as 5 ml instead of 10 ml.

    Product
    Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1285-2016·2016-04-06

    Ossur Recalls Knee Shields and Medical Devices Due to Packaging Defect

    Ossur Americas is recalling various medical devices, including knee shields and walkers, because the packaging is defective.

    Product
    Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
    Category
    Medical Device
    Distribution
    48 states
  • LowFDA (Drugs)·D-0783-2016·2016-04-06

    Praxair Recalls Medical Air Cylinders Due to Odor Complaint

    Praxair Inc. is recalling 382 cylinders of medical air nationwide after a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0800-2016·2016-04-06

    Pfizer Recalls Robitussin Peak Cold Liquid Due to Labeling Error

    Pfizer is recalling 63,636 bottles of Robitussin Peak Cold Liquid nationwide due to a label mix-up. Consumers should stop using the product and return it to the point of purchase.

    Product
    Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V190000·2016-04-05

    Hyundai Recalls 2011 Sonata Vehicles for Power Steering Defect

    Hyundai is recalling 2011 Sonata vehicles because a damaged circuit board may cause a loss of power steering assist, increasing the risk of a crash.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16736·2016-04-05

    Givenchy Recalls Men's Silk T-Shirts for Flammability Violation

    Givenchy is recalling about 60 men's silk T-shirts because they fail to meet federal flammability standards, posing a risk of burn injury.

    Product
    Givenchy men's silk T-shirts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E027000·2016-04-05

    Hale Recalls 6 Inch Suction Strainers Due to Soldering Defect

    Hale Products Inc. is recalling 6 Inch Suction Strainers manufactured between July 2015 and March 2016. Improper soldering may cause the strainer to break, potentially damaging fire pumps and increasing injury risk.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V191000·2016-04-05

    Nova Bus Recalls 2010-2015 LFS Transit Buses for Seat Belt Defect

    Nova Bus is recalling 2010-2015 LFS transit buses because missing welds on seat J-Brackets may allow seat belt anchorages to separate, increasing injury risk in a crash.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V189000·2016-04-04

    Kalmar Ottawa T2 Recalled for Inaccurate Brake Pressure Gauge

    Kalmar is recalling 2014-2016 Ottawa T2 vehicles because the brake system air pressure gauge may not display accurate levels, increasing crash risk.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E026000·2016-04-01

    Bosch Recalls Aftermarket Brake Pads for Ford, Lincoln, and Mercury Vehicles

    Bosch is recalling specific aftermarket front brake pads for 1993-2007 Ford, Lincoln, and Mercury vehicles because a shifting shim may damage the brake disc, potentially reducing braking power.

    Product
    FORD — FORD, LINCOLN, MERCURY TAURUS, TAURUS SHO, CONTINENTAL, SABLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V185000·2016-04-01

    Kompact Kamp Recalls Motorcycle Trailers Missing Side Marker Lights

    Kompact Kamp is recalling 1983-2016 Li'l Clipper motorcycle trailers manufactured without side marker lights, which may decrease visibility and increase crash risk.

    Product
    KOMPACT KAMP — KOMPACT KAMP LI'L CLIPPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V186000·2016-04-01

    Pierce Recalls 2010-2016 Vehicles Due to Flashlight Battery Fire Risk

    Pierce Manufacturing is recalling 2010-2016 Arrow-XT, Quantum, and Velocity vehicles because Pelican flashlights may overheat and cause a fire.

    Product
    PIERCE — PIERCE VELOCITY, QUANTUM, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide

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