The Recall Desk

Archive

June 2015 recalls

481 recalls were announced in June 2015.

What the numbers show

Critical
29
Severe
127
High
231
Moderate
74
Low
20

Of the 481 recalls this month scored against our rubric, 6% are Critical, 26% are Severe.

1–100 of 481

  • SevereCPSC·15737·2015-06-30

    Yamaha Recalls SRViper Snowmobiles Due to Brake Failure Risk

    Yamaha is recalling about 200 SRViper snowmobiles because the brake line can contact the clutch, causing brake failure and posing a risk of injury or death.

    Product
    Yamaha SRViper snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V412000·2015-06-30

    Oshkosh Recalls 2015 S-Series Trucks Due to Torque Converter Paint Issue

    Oshkosh is recalling 24 model year 2015 S-Series concrete mixer glider trucks because paint on the torque converter may soften, causing bolts to loosen and potentially leading to a loss of drive power.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V413000·2015-06-30

    Goshen Buses Recalled for Fraying Passenger Seat Belts

    Goshen Coach is recalling 2013-2015 buses because passenger seat belts may rub against metal frames and fray, potentially failing to restrain occupants in a crash.

    Product
    GOSHEN — GOSHEN IMPULSE, G-FORCE ACCESS, G-FORCE, G-FORCE LTD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15173·2015-06-30

    Technosport Recalls Omersub Scuba Mask Due to Shattering Lens Hazard

    Technosport is recalling Omersub Zero Cube scuba masks because non-conforming glass lenses can shatter during normal use, posing an injury hazard.

    Product
    Omersub Zero Cube scuba diving mask
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V416000·2015-06-30

    GM Recalls 2014-2015 Chevrolet Sonic and Spark for Radio Software Defect

    General Motors is recalling 2014-2015 Chevrolet Sonic and Spark vehicles because a radio software issue may disable safety warning chimes, increasing the risk of theft and injury.

    Product
    CHEVROLET — CHEVROLET SONIC, SPARK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V415000·2015-06-30

    GM Recalls SUVs for Power Liftgate Gas Strut Wear Risk

    General Motors is recalling 2007-2012 Buick Enclave, Chevrolet Traverse, GMC Acadia, and Saturn Outlook vehicles because power liftgate gas struts may wear prematurely, causing the liftgate to fall suddenly.

    Product
    GMC — GMC, CHEVROLET, BUICK ACADIA, TRAVERSE, ENCLAVE, OUTLOOK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V410000·2015-06-29

    Yamaha Recalls WR250X and WR250R Motorcycles Due to Stator Coil Defect

    Yamaha is recalling 2008-2015 WR250X and WR250R motorcycles because a stator coil defect may cause the battery to die and the engine to stall, increasing crash risk.

    Product
    YAMAHA — YAMAHA WR250X, WR250R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·095-2015·2015-06-26

    OFT Inc Recalls Beef Extracts Produced Without Import Inspection

    OFT Inc is recalling approximately 67,232 pounds of beef leg bone extract and beef concentrate products produced in Australia and New Zealand that were not presented for U.S. import inspection.

    Product
    OFT Inc Recalls Beef Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·15172·2015-06-25

    Little Digger Toy Recalled Due to Excessive Lead in Red Paint

    Northern Tool + Equipment is recalling Little Digger Toys because the red paint contains excessive lead levels prohibited by federal law.

    Product
    Little Digger Toy
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1818-2015·2015-06-24

    Hill-Rom Viking Mobile Patient Lifts Recalled for Potential Free Fall Hazard

    Hill-Rom is recalling Viking M, L, and XL Mobile Lifts because a damaged actuator can cause the lift arm to drop suddenly, posing a risk of patient injury or death.

    Product
    Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·15V405000·2015-06-24

    Shred-Tech MDS Vehicles Recalled for Front Axle Weight Rating Defect

    Shred-Tech is recalling specific MDS models because EPA emission controls cause the front axle to exceed its certified weight rating, increasing crash risk.

    Product
    SHRED-TECH — SHRED-TECH MDS-20GT, MDS-26GTX, MDS 2/26, MDS 1/26
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1731-2015·2015-06-24

    HeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures

    HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Food)·F-2441-2015·2015-06-24

    Whole Foods Market Muffin Bran Recalled for Undeclared Milk and Eggs

    Whole Foods Market is recalling Muffin Bran 6Pk packages due to undeclared milk and eggs. Consumers should check their pantries for affected products.

    Product
    BRAN Whole Foods Market Muffin Bran 6Pk packaged in clear plastic "clam shell" containers, NET WT. 12 oz., PLU 24857800499 Dist. by Whole Foods Market Austin, TX 78703
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1141-2015·2015-06-24

    NEXIUM Capsules Recalled Due to Presence of SEROQUEL XR Tablets

    AstraZeneca is recalling NEXIUM capsules because a retail pharmacist found SEROQUEL XR tablets in an unopened bottle.

    Product
    NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves

    Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2015·2015-06-24

    CareFusion Alaris PC Unit Infusion Pump Software Recall

    CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

    Product
    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V404000·2015-06-24

    Roadtrek Motorhomes Recall 2014 Models for Air Bag Wiring Defect

    Roadtrek is recalling 335 model year 2014 motorhomes because electrical wiring under the front seats may damage, preventing the optional front thorax air bags from deploying in a crash.

    Product
    ROADTREK — ROADTREK CS ADVENTUROUS, TS ADVENTUROUS, SS AGILE, RS ADVENTUROUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2438-2015·2015-06-24

    Byrds Famous Cookies Recalled for Undeclared Anchovies

    Byrd Cookie Company is recalling Byrds Famous Cookies, Benne Bits, because the product contains undeclared anchovies.

    Product
    Byrds Famous Cookies, Benne Bits, Net Wt. 6 oz. tins, UPC: 0-74882904651-8, Byrd Cookie Company, P.O. Box 1308, Savannah, GA 31416.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-2444-2015·2015-06-24

    Texas Pack Recalls Shrimp Due to Possible Glass Inclusion

    Texas Pack, Inc. is recalling 3,653 pounds of brown peeled shrimp in Texas due to a possible glass inclusion hazard.

    Product
    Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40, 41/50, 51/60, 61/70, 71/80, 81/90, Large Pcs, Medium Pcs.) I.Q.F P&D Round T/ON Net Weight 3 Lbs. (48 oz.) in plain bag and master; 18 lbs. per case, 6 bags per case. Wild Caught Gulf Shrim
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V403000·2015-06-24

    Spartan Emergency Vehicles Recalled for Engine Cooling Fan Defect

    Spartan Motors is recalling 2010-2015 Furion, Gladiator, and Metrostar emergency vehicles because the engine cooling fan may crack and detach, posing an injury risk to nearby individuals.

    Product
    SPARTAN — SPARTAN GLADIATOR, FURION, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2015·2015-06-24

    Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues

    Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.

    Product
    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is desig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E054000·2015-06-24

    Dannmar MaxJax Portable Car Lifts Recalled for Welding Defect

    Dannmar is recalling MaxJax Portable Two-Post automatic car lift systems due to insufficient welding on lower carriage plates, which could cause the lift arms to snap and the vehicle to fall.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2015·2015-06-24

    Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect

    Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.

    Product
    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked,
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1810-2015·2015-06-24

    Stryker Recalls Navigation System II-Cart Due to Weld Seam Defect

    Stryker is recalling 72 Navigation System II-Carts because a weld seam defect may cause the articulated arm joint to fail.

    Product
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2015·2015-06-24

    Boston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference

    Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.

    Product
    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H3012002022
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1693-2015·2015-06-24

    Neusoft NeuViz 64 CT Scanner Recalled for Teflon Compensator Failure

    Neusoft Medical System Co is recalling NeuViz 64 CT scanners because the Teflon A-plane compensator degrades under X-ray exposure, causing premature failure and image artifacts.

    Product
    Neusoft NeuViz 64 Multi-slice CT Scanner System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1802-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2015·2015-06-24

    BD Viper LT System Recalled for Potential False Positive Diagnostic Results

    Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.

    Product
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1796-2015·2015-06-24

    Mortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk

    Mortara Instrument is recalling 176 ELI 380 electrocardiographs because ECG waveforms may be incorrectly associated with the wrong patient's demographics when transmitted to records systems.

    Product
    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, prin
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1801-2015·2015-06-24

    Vidacare T.A.L.O.N Intraosseous Needle Recall for Potential Sterility Breach

    Vidacare Corporation is recalling T.A.L.O.N intraosseous needles due to a potential breach in sterility. The recall affects 2,104 boxes distributed in the US and internationally.

    Product
    T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1806-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves

    Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2015·2015-06-24

    Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.

    Product
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves

    Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2015·2015-06-24

    Neuro Kinetics Recalls I-Portal NOTC and VNG Devices Due to Malfunction

    Neuro Kinetics is recalling 140 I-Portal NOTC and VNG devices due to system malfunctions and unintended sudden movements at startup. No injuries have been reported.

    Product
    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15170·2015-06-24

    Positec Recalls Worx Electric Blower/Vacs Due to Shock Hazard

    Positec Tool Corp. is recalling Worx electric blower/vacs because reversed wiring poses a shock hazard. No injuries have been reported.

    Product
    Worx electric blower/vacs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15169·2015-06-24

    SR Suntour Bicycle Forks Recalled Due to Crash Hazard

    SR Suntour is recalling bicycles with specific fork models because a bolt can break, causing the front wheel to detach. This poses a crash hazard to riders.

    Product
    Bicycles with SR Suntour bicycle forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2015·2015-06-24

    Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage

    Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break during surgery.

    Product
    Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2015·2015-06-24

    Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding

    Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.

    Product
    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2015·2015-06-24

    Intuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage

    Intuitive Surgical is recalling 2,436 units of 5 mm Thoracic Graspers because coating damage could cause fragments to fall into patients.

    Product
    Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2439-2015·2015-06-24

    Byrds Famous Cookies Recalled for Undeclared Anchovies

    Byrd Cookie Company is recalling Vidalia Onion Biscuits because they contain undeclared anchovies, a common allergen.

    Product
    Byrds Famous Cookies, Vidalia Onion Biscuits, Net Wt. 3 oz. and 6 oz. tins, UPC: 0-74882904599-3 (6 oz) and 0-74882904605-1 (3 oz), Byrd Cookie Company, P.O. Box 1308, Savannah, GA 31416.
    Category
    Food
    Distribution
    14 states
  • HighCPSC·15736·2015-06-24

    School Specialty Recalls NeoRok Stools Due to Fall Hazard

    School Specialty is recalling about 1,350 NeoRok stools because they can break during use, posing a fall hazard. No injuries have been reported.

    Product
    Classroom Select NeoRok Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2440-2015·2015-06-24

    Garber's Birthday Cake Ice Cream Recalled for Undeclared Egg Allergen

    Garber Ice Cream Company is voluntarily recalling Birthday Cake Flavored Ice Cream because eggs were added to the cake component, creating an undeclared egg allergen.

    Product
    Garber's Old Fashioned Ice cream, Birthday Cake Flavored 1.75 quarts, packed in a shrink wrap of 3. #1 lot of 211/ 3 pk produced on 12/12/13 expires on 12/12/14 #2 lot of 451/3 pk produced on 3/31/14 expires 3/31/15 #3 lot of 454/3 pk produced on 11/5 14 expires on 1
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1134-2015·2015-06-24

    Allegiant Health Recalls Famotidine Tablets Due to Manufacturing Investigation Failures

    Allegiant Health is recalling specific lots of over-the-counter famotidine tablets because the manufacturer failed to adequately investigate customer complaints.

    Product
    Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1135-2015·2015-06-24

    Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications at the 9-hour time point.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2732-2015·2015-06-24

    Driscoll's Strawberries Recalled for Pesticide Naled Exceeding Tolerance

    Driscoll's is recalling fresh strawberries due to pesticide Naled levels exceeding EPA tolerance. Affected products were distributed in the US and Mexico.

    Product
    Fresh Driscoll Strawberries, 8 x 16 oz. clamshell, 4 x 32 oz. clamshell. Keep refrigerated Driscoll's Strawberries, Watsonville, CA
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1798-2015·2015-06-24

    Biomet Vanguard M Unicondylar Tibial Trial Recalled for Incorrect Etching

    Biomet, Inc. is recalling 27 Vanguard M Unicondylar Tibial Trials because the left and right orientation markings are incorrectly etched on the handle.

    Product
    Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1139-2015·2015-06-24

    West-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures

    West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection due to failed impurities and degradation specifications. The recall covers 14,649 cartons distributed nationwide.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1146-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain less than the labeled amount of active ingredients.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2015·2015-06-24

    AMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling

    MRP, LLC dba AMUSA is recalling 1,080 units of T/S2 0.9% Sodium Chloride Injection flush syringes due to incorrect expiration date labeling.

    Product
    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1814-2015·2015-06-24

    CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error

    CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.

    Product
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1800-2015·2015-06-24

    Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling

    Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.

    Product
    3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1136-2015·2015-06-24

    Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

    Dr. Reddy's Laboratories is recalling 5,160 bottles of Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1145-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is voluntarily recalling specific lots of Amlodipine and Atorvastatin tablets because they contain less active ingredient than labeled.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1140-2015·2015-06-24

    American Health Packaging Recalls Lamivudine and Zidovudine Tablets for Dissolution Failure

    American Health Packaging is recalling 925 cartons of Lamivudine and Zidovudine Tablets USP 150mg/300mg because they failed dissolution specifications.

    Product
    Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1138-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Inhalation Powder Due to Stability Failure

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a stability test for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1144-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is voluntarily recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain less than the labeled amount of active ingredients.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1142-2015·2015-06-24

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1143-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling specific lots of Amlodipine and Atorvastatin tablets because they contain less active ingredient than labeled.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2443-2015·2015-06-24

    Turkana Food Recalls Cotton Candy with Rose for Unapproved Dye

    Turkana Food Inc. is recalling Hacizade Pismaniye Pashmak cotton candy due to the presence of unapproved dye Ponceau 4R.

    Product
    Hacizade Pismaniye Pashmak (Cotton Candy with Rose), Net Wt. 250-g (8.80-oz.), UPC 8697407913372
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-2442-2015·2015-06-24

    Jose Madrid Salsa Mild Recalled Due to Convex Lid Defect

    Michael Zakany LLC is recalling Jose Madrid Salsa Mild because Ohio Department of Agriculture inspectors found jars with convex lids.

    Product
    Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 REFRIGERATE AFTER OPENING .0 93662 45252 2
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-1137-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Due to Failed Stability Testing

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a particle size distribution stability test. The recall covers 19,658 packs distributed in New Jersey.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·15E053000·2015-06-23

    Suzuki Recalls VZR1800 Accessory Backrest Mounting Hardware Kits

    Suzuki is recalling accessory backrest mounting hardware kits for 2006-2015 VZR1800 motorcycles because incorrect bolts may contact the rear tire, increasing crash risk.

    Product
    SUZUKI — SUZUKI VZR1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V400000·2015-06-23

    Starcraft RV Recalls 2014-2016 Trailers for Incorrect Tire Certification Labels

    Starcraft RV is recalling 50 model year 2014-2016 AR-ONE and Comet trailers because certification labels list the wrong tire size, which could lead to improper tire installation and increased crash risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT, STARCRAFT COMET, AR-ONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V397000·2015-06-23

    Forest River Recalls 2015 Dynamax Rev for Head Restraint Defect

    Forest River is recalling 2015 Dynamax Rev vehicles because front head restraints may exceed safety limits, increasing injury risk in rear-end collisions.

    Product
    DYNAMAX — DYNAMAX REV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V396000·2015-06-22

    Turtle Top Transit Buses Recalled for Electrical Fire Risk

    Turtle Top is recalling certain 2006-2014 transit buses and specialty vehicles because a loose electrical connection may cause a fire.

    Product
    TURTLE TOP — TURTLE TOP ODYSSEY LT, ODYSSEY, TERRA TRANSPORT, VANTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V393000·2015-06-22

    Jeep Cherokee Recall: Power Liftgate Module Fire Risk

    Chrysler is recalling 2014-2015 Jeep Cherokee vehicles with power liftgates because water intrusion may cause a short circuit and fire.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·094-2015·2015-06-20

    Shirk's Meats Recalls Pork and Beef Products Due to Listeria Risk

    Shirk's Meats is recalling approximately 2,478 pounds of pork and beef products in New York due to possible Listeria monocytogenes contamination.

    Product
    Timberline Meats, LLC — Shirk's Meats Recalls Pork and Beef Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V389000·2015-06-19

    MCI Motorcoaches Recalled for Hub Carrier Cracking and Oil Leaks

    Motor Coach Industries is recalling certain 2013-2015 D4500, D4505, and J4500 motorcoaches because hub carriers may crack or leak oil, potentially causing loss of vehicle control.

    Product
    MCI — MCI D4505, J4500, D4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15167·2015-06-19

    PetSmart Recalls Top Fin Plastic Aquarium Heaters Due to Electrical Shock Hazard

    PetSmart is recalling Top Fin plastic aquarium heaters due to an electrical problem that poses a risk of fire or electrical shock. Consumers should stop using the heaters and return them for a full refund.

    Product
    Top Fin Plastic Aquarium Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V390000·2015-06-19

    Forest River Recalls Trailers Due to Wheel Stud Breakage Risk

    Forest River is recalling specific model years of Auto Plus, Sandpiper, Vengeance, Cargo Mate, Hydra-Lift, and XLR trailers because wheel studs may break, potentially causing the wheel to detach.

    Product
    FOREST RIVER — FOREST RIVER HYDRA-LIFT, XLR, SANDPIPER, VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V391000·2015-06-19

    Champion Transit Bus Recall for Fraying Seat Belts

    Champion is recalling 2013-2015 transit buses because seat belts may rub against metal frames and fray, failing federal safety standards.

    Product
    CHAMPION — CHAMPION AMERICAN COACH, SPIRIT, AMERICAN CRUSADER, LF TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1726-2015·2015-06-17

    HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction

    HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Food)·F-2430-2015·2015-06-17

    Good Seed Recalls Soybean and Mung Bean Sprouts Due to Listeria Risk

    Good Seed, Inc. is recalling soybean and mung bean sprouts because they may be contaminated with Listeria monocytogenes, which can cause serious illness.

    Product
    1-lb, 2-lb and 10-lb bags of Soybean Sprouts in clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1706-2015·2015-06-17

    Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk

    Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.

    Product
    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Food)·F-2431-2015·2015-06-17

    Good Seed Recalls Mung Bean Sprouts Due to Listeria Risk

    Good Seed, Inc. is recalling mung bean sprouts in Virginia, Maryland, and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    1-lb, 2-lb and 10-lb bags of Mung Bean Sprouts in clear plastic bags labeled GOODSEED Mung Bean Sprouts Keep Refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1124-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.

    Product
    Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1750-2015·2015-06-17

    ResMed Astral Ventilator Recall Due to Alarm Disabling Hazard

    ResMed is recalling Astral 100 and 150 ventilators because clinicians can disable all alarms, including circuit disconnection alerts, posing a risk of insufficient ventilation.

    Product
    Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V386000·2015-06-17

    Land Rover Recalls LR4 Vehicles Due to Sunroof Adhesive Defect

    Jaguar Land Rover is recalling 2012-2013 LR4 vehicles because the panoramic roof adhesive may not secure the assembly, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER LR4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V384000·2015-06-17

    Trans Tech Student Safety Transport Recalled for Rear Axle Overload Risk

    Transportation Collaborative, Inc. is recalling 2012-2015 Trans Tech Student Safety Transport buses because the rear axle may fail if loaded to full capacity.

    Product
    TRANS TECH — TRANS TECH STUDENT SAFETY TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2433-2015·2015-06-17

    Sugar Free Vanilla Cake Recalled for Undeclared Milk Allergen

    AYAA Popcorn Manufacturing Corp. is recalling Sugar Free Vanilla Cake 2 oz. because FDA inspection found undeclared milk on the labels.

    Product
    Sugar Free Vanilla Cake 2 oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2436-2015·2015-06-17

    AYAA Corn Cake Recalled for Undeclared Milk Allergen

    AYAA Popcorn Manufacturing Corp. is recalling Corn Cake 10 oz and 14 oz packages because FDA inspection found undeclared milk on the labels.

    Product
    Corn Cake 10 oz and 14 oz
    Category
    Food
    Distribution
    0 states

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