The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
197
High
166
Moderate
184
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 32% are Severe.

Which agencies issued them

301–400 of 607

  • ModerateFDA (Devices)·Z-1328-2013·2013-05-22

    Iris Diagnostics Recalls iQ Control/Focus Sets Due to Performance Issues

    Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.

    Product
    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2013·2013-05-22

    Curity Staple Remover Kit Recalled Due to Supplier OTC Drug Issue

    Covidien is recalling Curity Staple Remover Kits because a supplier recalled OTC drug products used in the kits.

    Product
    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1310-2013·2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1394-2013·2013-05-22

    Grove Grow Notes Hawthorne Recalled for Unapproved Food Dyes

    S & M International Inc is recalling Grove Grow Notes Hawthorne because it contains unapproved dyes Ponceau 4R and FD&C Yellow #5.

    Product
    Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1306-2013·2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling 9,432 cutting electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1395-2013·2013-05-22

    Tasty Snacks Sour Plum Recalled for Undeclared Sulfites and Unallowed Dye

    S & M International Inc. is recalling Tasty Snacks Sour Plum in New York due to undeclared sulfites, unallowed dye, and undeclared colorant.

    Product
    Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F1396-2013·2013-05-22

    Lam Sheng Kee Mini Sausage Recalled for Undeclared Ingredients

    S & M International Inc. is recalling Lam Sheng Kee Mini Sausage Hong Kong Style due to undeclared FD&C Red #40 and minced fish.

    Product
    Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1295-2013·2013-05-22

    HeliPlug Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2013·2013-05-22

    Medtox Diagnostics Recalls PROFILE-V MEDTOXScan Drugs of Abuse Test System

    Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.

    Product
    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2013·2013-05-22

    Integra NeuraGen Nerve Guide Recalled for Pyrogen Deviation

    Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2013·2013-05-22

    Karl Storz VaporCut Electrode Recalled for Packaging Damage

    Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2013·2013-05-22

    Integra Recalls Suturable DuraGen Dural Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling Suturable DuraGen Dural Regenerative Matrix because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened colla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2013·2013-05-22

    American Medical Systems Recalls AMS 800 Urinary Control System Components

    American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2013·2013-05-22

    Integra Recalls CollaPlug Collagen Wound Dressings Due to Pyrogen Levels

    Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2013·2013-05-22

    AMS 800 Urinary Control System Components Recalled for Release Criteria Failures

    American Medical Systems is recalling 77 AMS 800 Control Pumps and Pressure-Regulating Balloons because they were released without meeting final product release criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2013·2013-05-22

    Integra Recalls DuraGen Plus Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling DuraGen Plus Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1387-2013·2013-05-22

    Hokkai Frozen Half Shell Oysters Recalled for Insanitary Conditions

    Hong Chang Corporation is recalling Hokkai Frozen Half Shell Oysters because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Hokkai Frozen Half Shell Oyster, 144 pcs/case.
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1336-2013·2013-05-22

    ACUVUE ADVANCE Contact Lenses Recalled for Incomplete Sealing

    Johnson & Johnson Vision Care is recalling ACUVUE ADVANCE contact lenses because a limited number of packages may not have been completely sealed.

    Product
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1392-2013·2013-05-22

    Juice Bar Solutions Recalls Add a Scoop Probiotic Due to Labeling Error

    Juice Bar Solutions is recalling 26 containers of Add a Scoop Probiotic because the label claimed the product was GMO-free, but manufacturer paperwork did not support this claim.

    Product
    Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato
    Category
    Food
    Distribution
    10 states
  • LowFDA (Devices)·Z-1303-2013·2013-05-22

    Curity I.V. Start Kit Recalled Due to Supplier Component Issue

    Covidien is recalling Curity I.V. Start Kits because a supplier recalled a povidone-iodine applicator used in the kits.

    Product
    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1331-2013·2013-05-22

    DePuy LifeLiner Gloves Recalled for Mispackaging

    DePuy Orthopaedics is recalling LifeLiner Stick and Cut Resistant Gloves because right-handed packages contained left-handed gloves.

    Product
    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13734·2013-05-21

    Kubota Recalls ZG100 Series Riding Mowers Due to Fire Hazard

    Kubota is recalling about 8,600 ZG100 Series Zero Turn riding mowers because a fuel tank defect can cause leaks and fire. No injuries or property damage have been reported.

    Product
    Kubota ZG100 Series Zero Turn riding mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V212000·2013-05-21

    Triumph Recalls 2012-2013 Motorcycles Due to Transmission Defect

    Triumph is recalling 2012-2013 Speed Triple ABS motorcycles because an incorrect transmission spring may cause the bike to shift out of gear, increasing crash risk.

    Product
    TRIUMPH — TRIUMPH SPRINT GT, TIGER SPORT, TIGER 1050
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V215000·2013-05-21

    Triumph Recalls 2012 Motorcycles Due to Missing Throttle Cable Guide

    Triumph is recalling 2012 Daytona 675 and Street Triple motorcycles because missing throttle cable guides may impede steering and increase crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V209000·2013-05-17

    Elite Recalls 2012 Livestock Trailers Due to Brake Actuator Wear

    Elite Trailer Manufacturing is recalling 2012 Livestock Gooseneck trailers because a manufacturing defect in the hydraulic brake actuator could cause a loss of braking ability.

    Product
    ELITE — ELITE LIVESTOCK TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V214000·2013-05-17

    Pierce Emergency Vehicles Recalled for Door Handle Spring Defect

    Pierce is recalling 2007-2013 Velocity, Impel, and Dash CF emergency vehicles because door handle springs may be too weak to prevent doors from opening in a crash.

    Product
    PIERCE — PIERCE VELOCITY, IMPEL, DASH CF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V203000·2013-05-17

    Forest River Recalls 2013-2014 RVs for Power Awning Motor Defect

    Forest River is recalling 2013-2014 recreational vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER, PALOMINO, CARGO MATE WILDWOOD, WORK AND PLAY, XLR, MAVERICK TRUCK CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V206000·2013-05-16

    Isuzu Recalls 2013 N-Series Trucks Due to Transmission Defect

    Isuzu is recalling 1,161 model year 2013 N-Series trucks because a transmission retaining ring may dislodge, potentially causing the vehicle to stall and increasing crash risk.

    Product
    ISUZU — ISUZU N-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-314-2013·2013-05-15

    Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns

    Hospira Inc. is recalling 259,050 vials of Furosemide Injection due to a loose crimp on the vial cap that compromises sterility assurance.

    Product
    FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-316-2013·2013-05-15

    Hospira Recalls Sodium Acetate Injection Due to Sterility Concerns

    Hospira Inc. is recalling 266,900 vials of Sodium Acetate Injection due to loose crimps that may compromise sterility.

    Product
    SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-315-2013·2013-05-15

    Hospira Recalls QUELICIN Injection Due to Sterility Concerns

    Hospira Inc. is recalling QUELICIN (succinylcholine chloride) Injection due to a loose crimp on the vial that compromises sterility assurance.

    Product
    QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V204000·2013-05-15

    John Evans Recalls 2013-2014 Chassis and Trailers for Lug Nut Torque Defect

    John Evans is recalling 380 model year 2013-2014 chassis and trailers because wheel lug nuts may not be properly torqued, posing a crash risk.

    Product
    JOHN EVANS — JOHN EVANS, CHEETAH RMFD CHASSIS/TRAILER, CHASSIS/TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1198-2013·2013-05-15

    Cardinal Health Recalls Presource PBDS Extremity Circulator Kits

    Cardinal Health is recalling 4,571 Presource PBDS Extremity Circulator Kits because plastic packaging remnants may obstruct airflow.

    Product
    Presource PBDS, Extremity, Kit, Circulator
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1195-2013·2013-05-15

    Cardinal Health Recalls Presource PBDS General Laparoscopy Kits

    Cardinal Health is recalling 4,571 Presource PBDS General Laparoscopy Kits because plastic packaging remnants may obstruct airflow in the filter.

    Product
    Presource PBDS, General Laparoscopy, Kit, Circulator
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1245-2013·2013-05-15

    Abbott FreeStyle InsuLinx Blood Glucose Meter Recall for Inaccurate Readings

    Abbott is recalling FreeStyle InsuLinx meters because they may provide inaccurate readings at rare, extremely high glucose levels (1024 mg/dL and above).

    Product
    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V225000·2013-05-15

    GM Recalls 2011-2013 Chevrolet Express and GMC Savana Vans for Fire Risk

    General Motors is recalling 2011-2013 Chevrolet Express and GMC Savana vans with factory-installed CNG systems due to a corroding fuel connector that may cause a fire.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2013·2013-05-15

    Maple View Farm Ice Cream Recalled for Undeclared Wheat and Soy

    Maple View Farm Ice Cream is recalling Cookies and Cream ice cream because it contains undeclared wheat and soy.

    Product
    Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1277-2013·2013-05-15

    Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke

    Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.

    Product
    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise

    Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2013·2013-05-15

    Symmetry Medical Recalls Collins Radioparent Sternal Blades Due to Breakage Risk

    Symmetry Medical is recalling Collins Radioparent Sternal Blades because they may break during use. The recall covers 524 boxes distributed worldwide.

    Product
    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
    Category
    Medical Device
    Distribution
    11 states
  • HighNHTSA·13V198000·2013-05-15

    Gulf Stream Recalls 2013 RV Trailers Due to Awning Motor Defect

    Gulf Stream is recalling 2013 RV trailers because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    GULF STREAM — GULF STREAM KINGSPORT, SEDONA, CANYON TRAIL, TRAIL MASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1377-2013·2013-05-15

    Maple View Farm Ice Cream Recalled for Undeclared Allergens

    Maple View Farm Ice Cream is recalling Carolina Crunch pints due to undeclared peanuts, almonds, and soy.

    Product
    Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1194-2013·2013-05-15

    Cardinal Health Recalls Presource Lap Chole Kits Due to Airflow Obstruction Risk

    Cardinal Health is recalling 4,571 Presource Lap Chole Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.

    Product
    A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·13V200000·2013-05-15

    Blue Bird Recalls School Buses with Flip Seat Pinch Hazard

    Blue Bird is recalling 2010-2014 All American and Vision school buses equipped with specific C. E. White Flip Seats due to a risk of foot or toe pinch injuries.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Ultra Embryo Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2013·2013-05-15

    Maple View Farm Ice Cream Recalled for Undeclared Wheat and Soy Allergens

    Maple View Farm Ice Cream is recalling Cookie Dough flavor pints because they contain undeclared wheat and soy allergens.

    Product
    Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1244-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling 800 Wallace Sure-Pro Single Stage Embryo Replacement Catheters because the catheter cannot be passed through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the adde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13191·2013-05-15

    Optimus Recalls Portable Electric Heaters Due to Fire Hazard

    Optimus is recalling about 355,000 portable electric heaters because they can ignite nearby combustible materials, posing a fire hazard. No injuries have been reported.

    Product
    Portable Infrared Radiant Quartz Electric Space Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2013·2013-05-15

    Smiths Medical Recalls Embryo Replacement Catheters Due to Transfer Failure

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2013·2013-05-15

    Siemens MicroScan MICroSTREP panels recalled for false susceptibility results

    Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.

    Product
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2013·2013-05-15

    Smiths Medical Recalls Sure-Pro Ultra Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2013·2013-05-15

    Cypress Medical Recalls MediChoice Umbilical Cord Clamps Due to Breakage

    Cypress Medical Products LLC is voluntarily recalling one lot of MediChoice Umbilical Cord Clamps because they are breaking upon use.

    Product
    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1238-2013·2013-05-15

    Synthes Radial Head Prosthesis Recalled Due to Potential Component Separation

    Synthes USA is recalling 417 trial radial head prostheses because the trial head may come loose from the implant stem during surgery. No adverse events have been reported.

    Product
    Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ asse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1216-2013·2013-05-15

    Karl Storz Recalls Photodynamic Diagnosis Instruction Manuals for Safety Updates

    Karl Storz is recalling 15 units of PDD D-Light C System instruction manuals because they contain important safety-related changes.

    Product
    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1259-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 60mm Straight Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1278-2013·2013-05-15

    DePuy Mitek Tissue Liberator Recalled for Incorrect Labeling

    DePuy Mitek is recalling 27 Tissue Liberator instruments labeled as Blade Up instead of Blade Down. The mislabeling could lead to incorrect instrument use during surgery.

    Product
    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1255-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1263-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 100mm Straight Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1276-2013·2013-05-15

    Medshape ExoShape Soft Tissue Fastener Recalled for Labeling Date Discrepancy

    Medshape Solutions is recalling 26 ExoShape Soft Tissue Fasteners because the expiration date on the patient label did not match the date on the product carton.

    Product
    ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1380-2013·2013-05-15

    Winn-Dixie Organic Apple Juice Recalled for Potential Patulin Levels

    Winn-Dixie Logistics is recalling 6,104 bottles of Organic 100% Apple Juice because it may contain patulin levels exceeding FDA limits.

    Product
    Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1228-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2013·2013-05-15

    Smiths Medical Recalls Embryo Replacement Catheters Due to Functional Defect

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro and Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System lordosed rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1253-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1230-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1261-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System straight rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1227-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1219-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed an incorrect pre-vacuum steam sterilization temperature.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1222-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System straight rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1224-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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