The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
216
High
442
Moderate
156
Low
24

Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.

501–600 of 896

  • SevereNHTSA·16V426000·2016-06-10

    PACCAR Recalls 2017 Kenworth and Peterbilt Trucks Due to Engine Stall Risk

    PACCAR is recalling 2017 Kenworth and Peterbilt trucks because a defective engine control module may cause the engine to stall without warning, increasing crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T660, 367, 579, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E055000·2016-06-10

    Hendrickson Bridge Axles Recalled for Potential Seam Weld Cracks

    Hendrickson is recalling specific bridge axles manufactured in late 2015 and early 2016 because tube sleeves may crack, potentially causing the axle to detach from the vehicle.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V424000·2016-06-10

    Maserati Recalls 2014 Quattroporte and Ghibli for Gear Indicator Defect

    Maserati is recalling 2014 Quattroporte and Ghibli vehicles because the gear indicator may mislead drivers about the transmission position, creating a risk of injury when exiting.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V425000·2016-06-10

    Vermeer Recalls TG5000 Trailers Due to Kingpin Assembly Defect

    Vermeer is recalling 2014-2016 TG5000 Tub Grinder trailers because incorrectly installed spherical washers may cause the kingpin to detach, increasing crash risk.

    Product
    VERMEER — VERMEER TG5000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16194·2016-06-10

    Auldey Toys Recalls Sky Rover Toys Due to Fire Hazard

    Auldey Toys is recalling Sky Rover toys because the included yellow USB charging cords can overheat, posing fire and burn hazards.

    Product
    Sky Rover toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V422000·2016-06-10

    GM Recalls 2013-2016 Chevrolet Vehicles for Missing Seatbelt Warning Chime

    General Motors is recalling specific Chevrolet Spark, Sonic, and Trax vehicles because the radio software may fail to provide audible seatbelt or key-in-ignition warnings.

    Product
    CHEVROLET — CHEVROLET SPARK, SONIC, TRAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V417000·2016-06-09

    Honda Recalls 2015-2016 Odyssey, MDX, and Pilot for Fuel Tank Welds

    Honda is recalling specific 2015-2016 Odyssey, Acura MDX, and Pilot vehicles because fuel tank welds may separate, causing a leak that could lead to a fire.

    Product
    HONDA — HONDA, ACURA ODYSSEY, MDX, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V418000·2016-06-09

    Daimler Recalls 2008-2009 Sterling Bullet Trucks Due to Air Bag Defect

    Daimler Trucks is recalling 2008-2009 Sterling Bullet 4500 and 5500 chassis cabs because passenger air bag inflators may rupture, posing a risk of serious injury or death.

    Product
    STERLING — STERLING BULLET 5500, BULLET 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V420000·2016-06-09

    Toyota Recalls Vehicles with Incorrect Load Carrying Capacity Labels

    Southeast Toyota Distributors is recalling 2015-2016 Toyota and Scion vehicles because the load carrying capacity label may be incorrect, potentially leading to vehicle overload.

    Product
    TOYOTA — TOYOTA, SCION TUNDRA, TC, HIGHLANDER, FR-S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V415000·2016-06-09

    Audi Recalls 2007-2009 A8 and S8 Models for Sunroof Glass Defect

    Volkswagen Group of America is recalling 2007-2009 Audi A8 and S8 vehicles because the sunroof glass may not be properly secured and could detach while driving.

    Product
    AUDI — AUDI A8, S8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16191·2016-06-09

    Rhino Metals Recalls Bighorn Handgun Safes Due to Security Flaw

    Rhino Metals is recalling Bighorn P-20 handgun security safes because they can be opened without a combination, posing a serious risk of injury to children and others.

    Product
    Bighorn handgun security safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V416000·2016-06-09

    Daimler Trucks Recalls 2017 Freightliner and Western Star Models for Engine Stall Risk

    Daimler Trucks is recalling specific 2017 Freightliner, Western Star, and FCCC trucks because an engine control module defect may cause the engine to stall without restarting, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR, FCCC CASCADIA, 122SD, 4900, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E054000·2016-06-09

    Ontario Recalls EVOS Full Face Modular Helmets for Safety Standard Failures

    1888653 Ontario Inc. is recalling specific EVOS Full Face Modular Helmets that may not adequately protect the wearer's head in a crash and lack required safety labeling.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V419000·2016-06-09

    Forest River Recalls 2017 Georgetown Motorhomes Due to Overloading Risk

    Forest River is recalling 2017 Georgetown motorhomes because extra seat belts allow more passengers than the vehicle's weight rating supports, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1416-2016·2016-06-08

    Kroger Salted Sunflower Kernels Recalled for Listeria Contamination

    The Kroger Co is recalling Salted Sunflower Kernels because the supplier notified the firm that the product may be contaminated with Listeria monocytogenes.

    Product
    Kroger SALTED SUNFLOWER KERNELS 6 oz (170g) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 61877 1
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1415-2016·2016-06-08

    Kroger Sunflower Kernels Recalled for Potential Listeria Contamination

    The Kroger Co is recalling Roasted & Salted Sunflower Kernels due to potential Listeria monocytogenes contamination.

    Product
    Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1414-2016·2016-06-08

    Kroger Cranberry Trail Mix Recalled for Potential Listeria Contamination

    The Kroger Co is recalling Cranberry Delight Trail Mix because it may be contaminated with Listeria monocytogenes.

    Product
    Kroger CRANBERRY DELIGHT TRAIL MIX NET WT 14 OZ INGREDIENTS: DRIED CRANBERRIES ***ALMONDS, SUNFLOWER SEEDS*** UPC 0 11110 89869 2 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1413-2016·2016-06-08

    FDA Recalls Fresh Long Chili Peppers Due to Salmonella Contamination

    Patel Shippers Inc is recalling fresh long chili peppers imported from the Dominican Republic because they tested positive for Salmonella.

    Product
    Fresh Long Chili Peppers, Raw, 10 lb box. Imported from Dominican Republic.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0937-2016·2016-06-08

    Baptist Health Recalls Sodium Chloride IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling seven bags of Sodium Chloride 0.9% IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1851-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2016·2016-06-08

    Baptist Health Recalls TPN Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 86 bags of TPN 2 in Arkansas due to a lack of sterility assurance.

    Product
    TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1855-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2016·2016-06-08

    Curity All Purpose Sponges Recalled Due to Compromised Sterility

    FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.

    Product
    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0943-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 59 bags of Vancomycin 1000 mg in 250 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0927-2016·2016-06-08

    Baptist Health Recalls Hydromorphone IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling three bags of Hydromorphone 2 mg/mL IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V411000·2016-06-08

    Forest River Recalls 2015 Glaval Synergy Buses for Steering Defect

    Forest River is recalling 2015 Glaval Synergy transit buses because steering boxes may wear prematurely, risking loss of steering control.

    Product
    GLAVAL BUS — GLAVAL BUS SYNERGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0948-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 11 bags of Vancomycin IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0945-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 88 bags of Vancomycin 1500 mg in 270 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0942-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 47 bags of Vancomycin 750 mg in 250 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0918-2016·2016-06-08

    Baptist Health Recalls Ceftriaxone IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 32 bags of Ceftriaxone 2 gram in 100 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0914-2016·2016-06-08

    Baptist Health Recalls Ascorbic Acid Syringes Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 21 Ascorbic Acid 500 mg syringes in Arkansas due to a lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1853-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2016·2016-06-08

    Pentax Medical Recalls Video Duodenoscopes Due to CRE Infection Reports

    Pentax Medical is recalling 423 Video Duodenoscopes nationwide after reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

    Product
    Video Duodenoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0928-2016·2016-06-08

    Invanz IV Bags Recalled for Lack of Sterility Assurance

    Baptist Health Medical Towers Pharmacy is recalling 24 bags of Invanz 1 gram in 100 mL 0.45% NS due to lack of sterility assurance.

    Product
    Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0916-2016·2016-06-08

    Baptist Health Recalls Ceftriaxone IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Ceftriaxone IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0912-2016·2016-06-08

    Baptist Health Pharmacy Recalls 1/2 Normal Saline Bags for Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 7 bags of 1/2 Normal Saline due to lack of sterility assurance. The product was distributed in Arkansas.

    Product
    1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0934-2016·2016-06-08

    Baptist Health Recalls 14 Bags of Piperacillin-Tazobactam Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 14 bags of IV piperacillin-tazobactam in Arkansas due to a lack of sterility assurance.

    Product
    Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0938-2016·2016-06-08

    Baptist Health Recalls TPN Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling seven bags of TPN 1 (amino acid 20%) in Arkansas due to a lack of sterility assurance.

    Product
    TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0921-2016·2016-06-08

    Baptist Health Recalls Daptomycin Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 14 bags of Daptomycin 650 mg in 50 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1847-2016·2016-06-08

    Curity Gauze Sponges Recalled for Compromised Sterility

    Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0924-2016·2016-06-08

    Deferoxamine Injection Syringes Recalled for Lack of Sterility Assurance

    Baptist Health Medical Towers Pharmacy recalled Deferoxamine syringes in Arkansas due to lack of sterility assurance.

    Product
    Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1856-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1859-2016·2016-06-08

    Recall of Vistec X-Ray Detectable Sponges Due to Sterility Breach

    Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised sterility.

    Product
    Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0946-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 54 bags of Vancomycin 1750 mg in 270 mL 0.9% NS due to a lack of sterility assurance. The product was distributed in Arkansas.

    Product
    Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0944-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 84 bags of Vancomycin 1250 mg in 250 mL 0.9% NS due to lack of sterility assurance.

    Product
    Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0949-2016·2016-06-08

    Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.

    Product
    Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0931-2016·2016-06-08

    Baptist Health Recalls Nafcillin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling seven bags of Nafcillin 3 grams in 277 mL 0.9% NS due to a lack of sterility assurance. The product was distributed in Arkansas.

    Product
    Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1854-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0925-2016·2016-06-08

    Baptist Health Pharmacy Recalls Dobutamine IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Dobutamine IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V413000·2016-06-08

    Terex Advance Recalls 2016 Concrete Mixer Trucks Due to Chute Failure

    Terex Advance is recalling 338 model year 2016 Front Discharge Concrete Mixer trucks because a weld failure could cause the main chute to detach while driving, increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0913-2016·2016-06-08

    Baptist Health Recalls 70% Ethanol-lock Solution Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 18 syringes of 70% Ethanol-lock Solution in Arkansas due to a lack of sterility assurance.

    Product
    70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0915-2016·2016-06-08

    Baptist Health Recalls Cefazolin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 11 bags of Cefazolin 6 grams in 292 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0920-2016·2016-06-08

    Baptist Health Recalls IV Fluid Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling six D5 1/2 NS IV fluid bags in Arkansas due to a lack of sterility assurance.

    Product
    D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0940-2016·2016-06-08

    Baptist Health Recalls Water for Injection Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 7 bags of Water for Injection in Arkansas due to a lack of sterility assurance.

    Product
    Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0947-2016·2016-06-08

    Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling two bags of Vancomycin IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1400-2016·2016-06-08

    World's Choice Products Recalls Multivitamin Juice for Undeclared Allergens

    World's Choice Products is recalling 610 bottles of New Life Nature's Blend 100% Multivitamin Juice because the product contains undeclared whey protein and soy lecithin.

    Product
    New Life Nature's Blend 100% Multivitamin Juice 32oz.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1848-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0910-2016·2016-06-08

    FDA Recalls Unapproved Ligandrol Supplements Sold Nationwide and in Brazil

    Invisiblu International LLC is recalling LGD-Xtreme capsules containing unapproved ligandrol because the product was marketed without an approved NDA or ANDA.

    Product
    LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0932-2016·2016-06-08

    Baptist Health Recalls Nafcillin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 11 bags of Nafcillin 12 grams in 322 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0929-2016·2016-06-08

    Baptist Health Recalls Meropenem IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 22 bags of Meropenem 2 grams in 100 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0919-2016·2016-06-08

    Baptist Health Recalls Clindamycin IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 16 bags of Clindamycin 900 mg in 100 mL 0.9% NS due to a lack of sterility assurance.

    Product
    Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0922-2016·2016-06-08

    Baptist Health Recalls Deferoxamine Cassettes Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling five Deferoxamine cassettes in Arkansas due to a lack of sterility assurance.

    Product
    Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1857-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.

    Product
    Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1314-2016·2016-06-08

    Harters Hawaiian Delight Salad Recalled for Missing Milk and Soy Allergens

    Frank L Harter & Sons Inc. is recalling Hawaiian Delight salad due to missing milk and soy allergen labeling.

    Product
    HAWAIIAN DELIGHT ING: IMITATION SOUR DRESSING, PEACHES, PINEAPPLE, MANDERIN ORANGES, SUGAR CHERRIES KEEP REFRIGERATED NET WT. 4.5 LB. & 9 LB. (4.06KG) (2.03KG) F.L. HARTER & SONS INC. CINCINNATI, OHIO 45211
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1881-2016·2016-06-08

    Orthofix Firebird NXG Spinal Fixation Set Screw Driver Recalled

    Orthofix is recalling 36 units of the Firebird NXG Spinal Fixation System Set Screw Driver because the tool may disengage from the handle during use.

    Product
    Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0926-2016·2016-06-08

    Baptist Health Recalls Ertapenem IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling ertapenem IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1841-2016·2016-06-08

    Miltex Chisel Blade Handle Recall Due to Insecure Blade Fit

    Integra York PA, Inc. is recalling Miltex Premium Grade Self-Lock Chisel Blade Handles because a wider slot may prevent the blade from securing firmly.

    Product
    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V409000·2016-06-08

    Crossroads Recalls 2016-2017 Trailers Due to Propane Fire Risk

    Crossroads is recalling 2016-2017 Hill Country and Sunset Trail trailers because opening the outside kitchen door may extinguish inside burners, allowing propane to build up and potentially cause a fire or explosion.

    Product
    CROSSROADS — CROSSROADS HILL COUNTRY, SUNSET TRAIL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0941-2016·2016-06-08

    Baptist Health Recalls Vancomycin Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Vancomycin IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1837-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.

    Product
    SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the s
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1844-2016·2016-06-08

    Skytron EZ Slide Operating Table Recalled for Potential Slide Cap Detachment

    Skytron is recalling 458 EZ Slide Operating Tables because incorrectly manufactured parts may cause the slide cap to detach, risking injury to patients or staff.

    Product
    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E053000·2016-06-08

    Thule Recalls Sprint Bicycle Carriers Due to Fork Clamping Defect

    Thule is recalling certain Sprint bicycle carriers because the fork clamping mechanism may not secure the bike, allowing it to detach from the vehicle.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16190·2016-06-08

    Kwik Tek Recalls Hammerhead Sleds Due to Crash Hazard

    Kwik Tek is recalling Hammerhead sleds because the front handle bar assembly can break, posing a crash hazard. No injuries have been reported.

    Product
    Sleds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1410-2016·2016-06-08

    Giant Eagle Pecan Tassies Recalled for Undeclared Milk Allergen

    Giant Eagle is recalling Pecan Tassies because the ingredient and allergen statements fail to declare milk. This poses a risk to consumers with milk allergies.

    Product
    Small Cookie Tray, PLU # 9793 Net Wt. 45 oz; . and Medium Cookie Tray, PLU #9794 Net Wt 90 oz.; and Large Cookie Tray, PLU #9795 Net Wt. 144 OZ. Sell by: (dates up to 5/4/2016) Giant Eagle, Inc., Pittsburgh, PA
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2016·2016-06-08

    Fujifilm ED-250XT5 Endoscope Manual Recall Due to Bacteria Reports

    Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2016·2016-06-08

    Windstone Medical Recalls General Surgery Packs with Medtronic Sponges

    Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.

    Product
    General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2016·2016-06-08

    Skytron Monitor Bracket Recalled for Weld Failure Risk

    Skytron is recalling 24 Ergon III Series monitor brackets because a weld failure could cause the display to fall and injure users.

    Product
    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1411-2016·2016-06-08

    Bridgewell Ivory Teff Flour Recalled for Potential Salmonella Contamination

    Bridgewell Resources LLC is recalling Ivory Teff Flour due to potential Salmonella contamination. The product was distributed in California and Washington.

    Product
    Ivory Teff Flour, bulk 25 lb bags. This product is a raw agricultural commodity and it is not a ready to eat product. It must go through further processing, including heat, before eating. Product is labeled in parts "***IVORY TEFF FLOUR***Origin: South Africa***distributed by
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1886-2016·2016-06-08

    Siemens Dimension Vista 1500 Lab System Software Defect Recall

    Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to discrepant patient results.

    Product
    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V410000·2016-06-08

    Oshkosh Recalls 2016 S-Series Concrete Mixers Due to Engine Stall Risk

    Oshkosh is recalling 2016 S-Series Front Discharge Concrete Mixers because a faulty engine control module may cause an unexpected engine stall, increasing crash risk.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2016·2016-06-08

    Remicade IV Bags Recalled for Lack of Sterility Assurance

    Baptist Health Medical Towers Pharmacy recalls Remicade IV bags in Arkansas due to lack of sterility assurance.

    Product
    Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1869-2016·2016-06-08

    Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2016·2016-06-08

    FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach

    The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.

    Product
    Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2016·2016-06-08

    Fujifilm ED-450XT5 Endoscope Manual Correction for Infection Risk

    Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0917-2016·2016-06-08

    Baptist Health Recalls Ceftriaxone IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 16 bags of Ceftriaxone 2 gram IV solution in Arkansas due to a lack of sterility assurance.

    Product
    Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1882-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0933-2016·2016-06-08

    Baptist Health Recalls Four Bags of Piperacillin-Tazobactam Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling four bags of Piperacillin-Tazobactam in Arkansas due to a lack of sterility assurance.

    Product
    Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1884-2016·2016-06-08

    Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.

    Product
    Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430,
    Category
    Medical Device
    Distribution
    3 states

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