The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
382
High
263
Moderate
177
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 41% are Severe.

801–900 of 921

  • CriticalFDA (Food)·F-1597-2016·2016-07-06

    Mccall Farms Recalls Piggly Wiggly Yellow Cut Corn for Listeria Risk

    Mccall Farms is recalling Piggly Wiggly Yellow Cut Corn due to possible Listeria monocytogenes contamination. The product was distributed in South Carolina.

    Product
    Piggly Wiggly, Yellow Cut Corn, Net Wt 32oz (2 lbs), 907g bags, Distributed by Piggly Wiggly LLC, Keene, NH 03431.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1583-2016·2016-07-06

    Pita Pal Mediterranean Three Bean Salad Recalled for Listeria Risk

    Pita Pal Foods LP is recalling specific Mediterranean Three Bean Salad products due to potential Listeria monocytogenes contamination.

    Product
    Pita Pal Mediterranean Three Bean Net Wt. 8 oz. (226g) UPC: 8-50157-0007-7 Keep Refrigerated Pita Pal Foods, LP Houston, TX 7003 www.pitapal.com; Pita Pal Mediterranean Three Bean Salad UPC: 8-50157-00048-0 Keep Refrigerated Net Wt: 24 oz.; Pita Pal Mediterranean Three Bean Salad
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·16V512000·2016-07-06

    Newmar Recalls 2017 Motorhomes Due to Front Fascia Wood Trim Separation Risk

    Newmar is recalling 152 model year 2017 motorhomes because front fascia wood trim may separate and contact occupants, potentially causing loss of vehicle control.

    Product
    NEWMAR — NEWMAR DUTCH STAR, KING AIRE, MOUNTAIN AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16214·2016-07-06

    Overstock Recalls Self-Balancing Scooters Due to Fire Hazard

    Overstock.com is recalling about 4,300 self-balancing scooters sold online from September to December 2015 because their lithium-ion batteries can overheat and catch fire.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2016·2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.

    Product
    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2016·2016-07-06

    Conagra Recalls Frozen Chicken and Beef Entrées Due to Metal Contamination

    Conagra Foods is recalling specific frozen P.F. Chang's Home Menu chicken and beef entrées due to possible metal contamination. No injuries have been reported.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • SevereCPSC·16210·2016-07-06

    Hoverboard LLC Recalls Self-Balancing Scooters Due to Fire Hazard

    Hoverboard LLC is recalling Powerboard self-balancing scooters because their lithium-ion batteries can overheat, smoke, catch fire, or explode. No injuries have been reported, but one instance of property damage occurred.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·16215·2016-07-06

    Razor Recalls Hoverboards Due to Fire and Explosion Risk

    Razor USA is recalling about 28,000 Hovertrax hoverboards because their lithium-ion batteries can overheat, smoke, catch fire, or explode.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·16211·2016-07-06

    Swagway Recalls Self-Balancing Scooters Due to Fire and Explosion Hazards

    Swagway is recalling X1 hoverboards because their lithium-ion batteries can overheat, smoke, catch fire, or explode. Consumers should stop using the units and contact Swagway for a repair or credit.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1574-2016·2016-07-06

    Reser's Deviled Egg Potato Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Deviled Egg Potato Salad due to potential Listeria monocytogenes contamination from a recalled onion lot.

    Product
    Reser's Deviled Egg Potato Salad, Refrigerated, Retail package, Net wt. 3 lbs. UPC 0 71117 00480 9; Reser's Deviled Egg Potato Salad, Refrigerated, Foodservice product, net wt. 8 lbs. UPC 71117 00225; Safeway Deviled Egg Potato Salad, Refrigerated, Net wt. 16 oz. UPC 0 2
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-1575-2016·2016-07-06

    Reser's Potato Salad Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling refrigerated potato salad products due to potential Listeria monocytogenes contamination from a recalled onion lot.

    Product
    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 3.5 oz. UPC 0 71117 17000 9. Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 5.5 oz. UPC 0 71117 17100 6. Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 8 oz.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Devices)·Z-2113-2016·2016-07-06

    Philips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard

    Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1580-2016·2016-07-06

    Reser's Potato Salad Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling Walmart Redskin Potato Salad due to potential Listeria monocytogenes contamination from a recalled onion lot.

    Product
    Walmart Redskin Potato Salad, Refrigerated, Retail net wt. 4lb. UPC 81131 91693 6.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Devices)·Z-2100-2016·2016-07-06

    Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk

    Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.

    Product
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2016·2016-07-06

    Philips Ingenuity Core 128 MRI Systems Recalled for Cover Crack Risk

    Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1578-2016·2016-07-06

    Safeway Classic Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Safeway Classic Potato Salad due to potential Listeria monocytogenes contamination from a recalled onion lot.

    Product
    Safeway Classic Potato Salad, Refrigerated, Retail package, net wt. 5.5oz. UPC 0 21130 06716 9.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-1577-2016·2016-07-06

    Stonemill Kitchens Potato Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Stonemill Kitchens Classic Potato Salad due to potential Listeria monocytogenes contamination from a recalled onion lot.

    Product
    Stonemill Kitchens Classic Potato Salad, Refrigerated, Retail net wt. 5lb. UPC 0 71117 61576 0.
    Category
    Food
    Distribution
    30 states
  • SevereCPSC·16218·2016-07-06

    Ten Firms Recall Self-Balancing Scooters Due to Fire and Explosion Hazards

    Ten companies are recalling about 501,000 self-balancing scooters because their lithium-ion batteries can overheat, catch fire, or explode. Consumers should stop using these products immediately.

    Product
    Self-Balancing Scooters/Hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2016·2016-07-06

    Medtest Homocysteine Reagent Recalled for Performance Deterioration

    Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.

    Product
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2079-2016·2016-07-06

    Pentax Medical Recalls Esophagoscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 405 esophagoscopes because operational accessories can become lodged in the instrument channel.

    Product
    Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult an
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2078-2016·2016-07-06

    Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the instrument channel.

    Product
    Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indicati
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2070-2016·2016-07-06

    Pentax Cystoscopes Recalled Due to Risk of Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 120 cystoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consist
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2115-2016·2016-07-06

    Philips Ingenuity Core MRI Scanner Recalled for Cover Crack Risk

    Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2090-2016·2016-07-06

    Smith & Nephew Recalls Legion HK Femoral Assemblies for Surface Defect

    Smith & Nephew is recalling 12 units of Legion HK Femoral Assemblies because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2016·2016-07-06

    Medical Depot Recalls Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Universal Quick Adjust aluminum crutches because the metal tips may fail and detach from the ground.

    Product
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1054-2016·2016-07-06

    Vital Care Compounder Recalls Methylcobalamin Vials Due to Sterility Concerns

    Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml because aluminum crimps may not fully seal the rubber stoppers, compromising sterility.

    Product
    Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2085-2016·2016-07-06

    Medtronic Recalls Sagittal Saw Devices Due to Potential Fluid Leakage

    Medtronic is recalling 368 Sagittal Saw devices because testing identified a potential for fluid leakage into the motor during use.

    Product
    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2068-2016·2016-07-06

    Pentax Medical Recalls Colonoscopes Due to Lodged Accessories

    Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Colonoscope 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 the rectum when in
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2076-2016·2016-07-06

    Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk

    Pentax Medical is recalling 115 Ultrasound Bronchoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including acc
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2065-2016·2016-07-06

    Pentax Medical Recalls Bronchoscopes Due to Lodged Accessories

    Pentax Medical is recalling 4,195 bronchoscopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2062-2016·2016-07-06

    Hospira Recalls LifeShield IV Sets Due to Potential Fluid Leakage

    Hospira is recalling approximately 3.9 million LifeShield IV administration sets because fluid may leak at the secondary port.

    Product
    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2016·2016-07-06

    CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data

    CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.

    Product
    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2016·2016-07-06

    Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2055-2016·2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms

    Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2016·2016-07-06

    Medical Depot Aluminum Crutches Recalled Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Direct Supply aluminum crutches because the metal tips may fail.

    Product
    Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2016·2016-07-06

    Medical Depot Universal Aluminum Crutches Recalled for Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Universal aluminum crutches because the bottom metal tips may fail.

    Product
    Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1591-2016·2016-07-06

    Eban's BAKEHOUSE Crispy Pecan Shortbread Cookies Recalled for Coconut Allergen Mislabeling

    Eban Bakery is recalling Crispy Pecan Shortbread Cookies because the label failed to list coconut in the 'Contains' section, despite it being in the ingredients.

    Product
    Product is labeled as "eban's BAKEHOUSE CRISPY PECAN SHORTBREAD COOKIES Net Weight 8.5 oz (241g) " . The cookies are packaged 6 per container. The container is a plastic tub with lid and tamper proof band.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V510000·2016-07-06

    MCI Recalls 2015-2016 J4500 Buses Due to Window Hardware Defect

    Motor Coach Industries is recalling 2015-2016 J4500 buses because improperly installed window hardware may allow windows to open unexpectedly, increasing ejection risk.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2016·2016-07-06

    Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or th
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2080-2016·2016-07-06

    Pentax Small Bowel Scope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adul
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1596-2016·2016-07-06

    Riba Foods Recalls Bayou Brothers Creole Sauce for Undeclared Fish

    Riba Foods Inc is recalling Bayou Brothers Creole Sauce because it contains undeclared fish. The product was distributed in Texas.

    Product
    Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1055-2016·2016-07-06

    Vital Care Compounder Recalls Brilliant Blue G Injection Vials

    Vital Care Compounder is recalling 9 vials of Brilliant Blue G injection due to a defect in the aluminum crimps that may compromise sterility.

    Product
    Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2098-2016·2016-07-06

    CMP Industries Recalls Impak Elastic Acrylic Resin Due to Rust

    CMP Industries is recalling Impak Elastic Acrylic Resin Powder and Liquid due to the possible presence of foreign material, specifically rust.

    Product
    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
    Category
    Medical Device
    Distribution
    6 states
  • HighCPSC·16212·2016-07-06

    Boscov's Recalls Orbit Hoverboards Due to Fire and Explosion Hazard

    Boscov's is recalling Orbit brand self-balancing scooters because their lithium-ion batteries can overheat, posing a risk of fire or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16217·2016-07-06

    Hype Wireless Recalls Self-Balancing Scooters Due to Fire Hazard

    Hype Wireless is recalling about 25,000 Roam brand self-balancing scooters because their lithium-ion batteries can overheat, posing a risk of smoking, fire, or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16216·2016-07-06

    Keenford Recalls iMoto Hoverboards Due to Fire and Explosion Risks

    Keenford Limited is recalling about 84,000 iMoto self-balancing scooters because their lithium-ion batteries can overheat, smoke, catch fire, or explode.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16756·2016-07-06

    Little Lotus Baby Swaddles and Sleeping Bags Recalled for Choking Hazard

    Embrace Technologies is recalling Little Lotus baby swaddles and sleeping bags because shoulder snaps can break or detach, posing a choking hazard to young children.

    Product
    Little Lotus baby swaddles and sleeping bags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16208·2016-07-06

    PTX Performance Products Recalls Airwalk Hoverboards Due to Fire Hazard

    PTX Performance Products is recalling about 4,900 Airwalk self-balancing scooters because the lithium-ion batteries can overheat, posing a risk of fire or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16209·2016-07-06

    Yuka Clothing Recalls Self-Balancing Scooters Due to Fire Hazard

    Yuka Clothing is recalling about 800 self-balancing scooters sold nationwide and online because the lithium-ion battery packs can overheat, posing a risk of smoking, fire, or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2016·2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.

    Product
    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For res
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2108-2016·2016-07-06

    Beckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts

    Beckman Coulter is recalling Access Free T3 Assay kits because they may show an upward shift in patient results. The recall covers 205,744 kits distributed worldwide.

    Product
    Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2049-2016·2016-07-06

    Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks

    Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.

    Product
    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2071-2016·2016-07-06

    Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories

    Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.

    Product
    Gastroscope 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 introduced via the mouth w
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2067-2016·2016-07-06

    Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging

    Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.

    Product
    Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the w
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2105-2016·2016-07-06

    Medical Depot Recalls Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Universal Quick Adjust aluminum crutches because the metal tips may fail.

    Product
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2016·2016-07-06

    Siemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures

    Siemens Healthcare Diagnostics Inc. is recalling 487 Hettich Centrifuge Modules due to premature bucket failures. The units were distributed nationwide.

    Product
    Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substanc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2016·2016-07-06

    Alcon CENTURION Vision System Recalled for Power Switch Defect

    Alcon Research, Ltd. is recalling the CENTURION Vision System because the grounding pin in the power entry switch may detach when the AC power cable is removed.

    Product
    CENTURION Vision System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2066-2016·2016-07-06

    Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel

    Pentax Medical is recalling 126 Choledocho-Nephroscope units because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, K
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2111-2016·2016-07-06

    Philips CT Scanner Recall Due to Potential Cover Cracking Hazard

    Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.

    Product
    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2092-2016·2016-07-06

    Smith & Nephew Legion Hinge Knee Femoral Assembly Recall

    Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1588-2016·2016-07-06

    Ross Chocolates Recalls Dark Chocolate Bars for Undeclared Milk Allergen

    Ross Chocolates is recalling 4,128 bars of No Sugar Added Dark Chocolate because the labels failed to declare the possible milk allergen.

    Product
    R No Sugar Added; Dark Chocolate 34 g/1.2 oz. Ross Chocolates, 4061 Butters Road, Scotch Creek, BC UPC 726007100054 Best Before: 191018
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2016·2016-07-06

    Medical Depot Recalls EZ Adjust Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of EZ adjust aluminum crutches because the tip may fail, posing a risk of injury.

    Product
    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ ad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2016·2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    Product
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2016·2016-07-06

    Hospira Recalls IV Administration Sets Due to Fluid Leakage Risk

    Hospira is recalling specific lots of Lifeshield IV administration sets because intravenous fluid may leak at the secondary port.

    Product
    *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2016·2016-07-06

    Pentax Confocal GI Scope Recall Due to Lodged Accessories

    Pentax Medical is recalling 17 Confocal GI Scopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2093-2016·2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 16 units of the Legion HK Femoral Assembly because the internal surface where cement is applied is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2016·2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms

    Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2016·2016-07-06

    Pentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk

    Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introd
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2101-2016·2016-07-06

    Medical Depot Recalls Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of aluminum crutches nationwide because the metal tip may fail. Users should stop using the product.

    Product
    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2016·2016-07-06

    Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories

    Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Signmoidoscope 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 introduced via the rectu
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2053-2016·2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.

    Product
    Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indica
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2077-2016·2016-07-06

    Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying a
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2059-2016·2016-07-06

    Hospira Recalls LifeShield IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific LifeShield IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    Product
    *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2116-2016·2016-07-06

    Philips Brilliance 64 CT Scanner Recall for Image Artifacts

    Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

    Product
    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2016·2016-07-06

    Smith & Nephew Recalls Legion Hinge Knee Femoral Assemblies

    Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2016·2016-07-06

    Actavis Recalls Ciprofloxacin Ophthalmic Solution Due to Impurity

    Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution due to out-of-specification results for an unknown impurity near expiration.

    Product
    Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1053-2016·2016-07-06

    Aloe Source Recalls Topical Analgesic Products Due to Manufacturing Deviations

    The Aloe Source is voluntarily recalling specific lots of aloe SPORT liniment and eucalyptus cream due to CGMP deviations.

    Product
    aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1052-2016·2016-07-06

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they were manufactured using active ingredients that failed specifications.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2016·2016-07-06

    Siemens Recalls SYNGO Breast Care Software Due to Display Issues

    Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.

    Product
    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2089-2016·2016-07-06

    CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust

    CMP Industries is recalling specific lots of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected products are used for dental applications.

    Product
    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS &
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2110-2016·2016-07-06

    Philips Big Bore Radiology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 89 Big Bore Radiology scanners because adjustment plate screws were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2057-2016·2016-07-06

    Dynarex Recalls Specimen Containers Due to Incorrect Sterile Labeling

    Dynarex Corporation is recalling non-sterile specimen containers that were mistakenly packed in cartons labeled as sterile. The recall covers specific lots distributed in the US and Canada.

    Product
    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2016·2016-07-06

    Integra LifeSciences Recalls METASURG Capture Screw System K-wires

    Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.

    Product
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2097-2016·2016-07-06

    CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust

    CMP Industries is recalling 77 units of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected product is distributed in six US states and Canada.

    Product
    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), R
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2095-2016·2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 97 units of the Legion HK Femoral Assembly because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity lev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2016·2016-07-06

    Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1056-2016·2016-07-06

    Vital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns

    Vital Care Compounder is recalling 54 vials of Trypan Blue 0.3% because aluminum crimps may not fully seal the rubber stopper, compromising sterility.

    Product
    Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2117-2016·2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2094-2016·2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 10 units of Legion HK Femoral Assemblies because the internal cement surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity leve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2016·2016-07-06

    Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error

    Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.

    Product
    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2112-2016·2016-07-06

    Philips Brilliance iCT Scanner Recall Due to Cracking Cover

    Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.

    Product
    Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2118-2016·2016-07-06

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts

    Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2016·2016-07-06

    Siemens Syngo.plaza PACS Software Recall for Database Error

    Siemens is recalling 74 Syngo.plaza PACS systems due to a software error that may create duplicate image references in the database.

    Product
    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2099-2016·2016-07-06

    Dako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration

    Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.

    Product
    Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1059-2016·2016-07-06

    Valeant Recalls Secobarbital Sodium Capsules Due to Missing Anaphylaxis Warning

    Valeant Pharmaceuticals is recalling 958 bottles of SECONAL SODIUM capsules because the package insert is missing a warning regarding anaphylaxis.

    Product
    SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1057-2016·2016-07-06

    KVK-Tech Recalls Benzphetamine Hydrochloride Tablets Due to Cosmetic Scuffing

    KVK-Tech, Inc. is recalling specific lots of Benzphetamine Hydrochloride Tablets due to cosmetic scuffing marks on the tablets.

    Product
    Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
    Category
    Drug
    Distribution
    Distributed nationwide

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