The Recall Desk

Archive

May 2014 recalls

394 recalls were announced in May 2014.

What the numbers show

Critical
29
Severe
101
High
158
Moderate
89
Low
17

Of the 394 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

201–300 of 394

  • HighNHTSA·14V253000·2014-05-15

    GM Recalls 2014 Cadillac CTS for Windshield Wiper Failure Risk

    General Motors is recalling 2014 Cadillac CTS vehicles because the windshield wipers may stop working after a jump start, increasing crash risk.

    Product
    CADILLAC — CADILLAC CTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1925-2014·2014-05-14

    Archer Farms Chocolate Hazelnut Swirl Gelato Recalled for Undeclared Peanut

    Sinco Inc. is recalling Archer Farms Chocolate Hazelnut Swirl Gelato because it contains undeclared peanut protein.

    Product
    Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1926-2014·2014-05-14

    Kroger Private Selection Sweet Strawberry Sorbet Recalled for Undeclared Milk

    Kroger is recalling Private Selection Sweet Strawberry Sorbet because it contains undeclared milk, posing a risk to consumers with milk allergies.

    Product
    PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: "INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA" 0 11110 52108 8
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1546-2014·2014-05-14

    Alere INRatio2 Test Strips Recalled for Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.

    Product
    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V255000·2014-05-14

    Lodal Recalls 2011-2013 Evo Garbage Trucks Due to Fire Risk

    Lodal is recalling 2011-2013 Evo garbage trucks because condensation in the intake manifold may freeze, causing sensor issues that increase the risk of vehicle fire or burn injury.

    Product
    LODAL — LODAL EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V247000·2014-05-14

    GM Recalls 2014 Chevrolet Malibu for Brake Vacuum Assist Loss

    General Motors is recalling specific 2014 Chevrolet Malibus because a software issue may cause a complete loss of brake vacuum assist, increasing stopping distance.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V252000·2014-05-14

    GM Recalls 2004-2012 Vehicles for Electronic Stability Control Defect

    General Motors is recalling 2004-2012 Chevrolet, Pontiac, and Saturn vehicles because a wiring issue can disable crash avoidance features like traction control.

    Product
    CHEVROLET — CHEVROLET, SATURN, PONTIAC MALIBU, AURA, G6, MALIBU MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V246000·2014-05-14

    GM Recalls 2014-2015 Trucks and SUVs for Steering Defect

    General Motors is recalling specific 2014 Chevrolet Silverado, 2014 GMC Sierra, and 2015 Chevrolet Tahoe vehicles because the steering tie rod may not be properly tightened, risking loss of steering.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, TAHOE, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2014·2014-05-14

    SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage

    SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.

    Product
    SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1924-2014·2014-05-14

    Bissinger's Dark Chocolate Bunny Ears Recalled for Undeclared Milk Allergen

    Karl Bissinger LLC is recalling Bissinger's Dark Chocolate Bunny Ears because milk chocolate is packaged in dark chocolate packaging without milk listed on the ingredient statement.

    Product
    Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. "point of purchase" display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted Chocola
    Category
    Food
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1559-2014·2014-05-14

    Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-1543-2014·2014-05-14

    Med-Mizer RetractaBed Recall Due to Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling 2,980 RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2014·2014-05-14

    Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk

    Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.

    Product
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1541-2014·2014-05-14

    Med-Mizer Retractabed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling 191 Retractabed Clinical Contour adjustable beds manufactured before June 7, 2008, due to insufficient welding that could cause bed collapse.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1561-2014·2014-05-14

    Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Drugs)·D-1308-2014·2014-05-14

    Mangiacotti Ginger Lime Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Ginger Lime Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1542-2014·2014-05-14

    Med-Mizer RetractaBed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse or rollers to detach.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1919-2014·2014-05-14

    Bread Stop Honey Wheat Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling Honey Wheat Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1921-2014·2014-05-14

    Bread Stop Bakery Recalls Wheat Sourdough for Undeclared Soy Allergen

    Bread Stop Bakery is recalling 200 loaves of Wheat Sourdough bread because soy lecithin was used in manufacturing but not listed on the label.

    Product
    the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·14176·2014-05-14

    Cabela's Recalls Electronic Jerky Blaster Due to Fire Hazard

    Cabela's is recalling Electronic Jerky Blasters because the battery charger adapter can overcharge, causing the battery and adapter to overheat.

    Product
    Electronic Jerky Blaster
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2014·2014-05-14

    Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.

    Product
    Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1557-2014·2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, B
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1564-2014·2014-05-14

    Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results

    Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.

    Product
    Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2014·2014-05-14

    GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect

    GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1305-2014·2014-05-14

    Mangiacotti Ocean Hand Sanitizer Spray Recalled for Bacterial Contamination

    Mangiacotti is recalling Ocean Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria. Consumers should stop using the product.

    Product
    Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2014·2014-05-14

    GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.

    Product
    Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1553-2014·2014-05-14

    Siemens ADVIA Centaur XP Immunoassay System Recalled for Gas Spring Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay systems because gas springs may fail, causing the instrument cover to fall.

    Product
    ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2014·2014-05-14

    Teleflex Recalls Deknatel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.

    Product
    Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1556-2014·2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.

    Product
    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregn
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1917-2014·2014-05-14

    Bread Stop Bakery Recalls Amaranth Bread Due to Undeclared Soy

    Bread Stop Bakery is recalling 100 loaves of Amaranth bread because soy lecithin was used in manufacturing but not declared on the label.

    Product
    the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1922-2014·2014-05-14

    Bread Stop Bakery Recalls Flaxseed Bread Due to Undeclared Soy Allergen

    Bread Stop Bakery is recalling 80 loaves of Flaxseed Bread because an anti-stick spray containing soy lecithin was used during manufacturing, but soy was not declared on the label.

    Product
    the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1923-2014·2014-05-14

    Bread Stop Bakery Recalls Spelt and Millet Bread for Undeclared Soy

    Bread Stop Bakery is recalling 50 loaves of Spelt and Millet Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1306-2014·2014-05-14

    Mangiacotti Clementine Hand Sanitizer Spray Recalled for Bacterial Contamination

    Mangiacotti is recalling Clementine Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2014·2014-05-14

    Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets

    Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.

    Product
    Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2014·2014-05-14

    GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.

    Product
    Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arteri
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1538-2014·2014-05-14

    Biorep Atrial Lift System Recalled for Support Arm Detachment

    Biorep Technologies is recalling the Joseph Lamelas Atrial Lift System because the support arm may detach from the blade body during use.

    Product
    Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1549-2014·2014-05-14

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect

    GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1551-2014·2014-05-14

    GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect

    GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.

    Product
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology wi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1915-2014·2014-05-14

    Wegmans Recalls Easter Bread for Undeclared Egg Allergen

    Wegmans is recalling 17-ounce Easter Bread loaves because they contain egg, which is not listed on the label.

    Product
    Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1920-2014·2014-05-14

    Bread Stop Sourdough Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling 200 loaves of Sourdough Bread because soy lecithin was used in manufacturing but not declared on the label.

    Product
    the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1916-2014·2014-05-14

    Bread Stop Bakery Recalls Country White Bread for Undeclared Soy

    Bread Stop Bakery is recalling 150 loaves of Country White Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2014·2014-05-14

    AlloSource Recalls AlloFuse DBM Putty Due to Donor Hemodilution

    AlloSource, Inc. is recalling 29 units of AlloFuse DBM Putty 5cc because the donor was hemodiluted. The product is used as a bone graft extender in orthopedic applications.

    Product
    AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone g
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2014·2014-05-14

    Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the s
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1528-2014·2014-05-14

    INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly

    INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.

    Product
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The prim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1918-2014·2014-05-14

    Bread Stop Oatmeal Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling 150 loaves of Oatmeal Bread because an anti-stick spray containing soy lecithin was used during manufacture, and soy was not declared on the label.

    Product
    the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1537-2014·2014-05-14

    Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues

    Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.

    Product
    Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separatio
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1544-2014·2014-05-14

    Stryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps

    Stryker Endoscopy is recalling 2,591 12-Instrument Sterilization Trays because gravity sterilization parameters in the reprocessing guide did not fully consider all worst-case scenarios during validation testing.

    Product
    12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and li
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1554-2014·2014-05-14

    Bausch & Lomb Recalls Biotrue Multi-Purpose Contact Lens Solution

    Bausch & Lomb is recalling Biotrue Multi-Purpose Contact Lens Solution due to out-of-specification results for a disinfectant.

    Product
    Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1301-2014·2014-05-14

    Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals

    Blu Pharmaceuticals is recalling 14,000 Metformin Hydrochloride tablets because the bottles were distributed without inner seals. The affected product was distributed in New Jersey, Utah, Illinois, and Connecticut.

    Product
    Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1302-2014·2014-05-14

    Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals

    Blu Pharmaceuticals is recalling Metformin Hydrochloride 1000 mg tablets because bottles were distributed without inner seals. The affected lot was distributed in New Jersey, Utah, Illinois, and Connecticut.

    Product
    Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1307-2014·2014-05-14

    Mangiacotti Pomegranate Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Pomegranate Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1304-2014·2014-05-14

    Mangiacotti Lavender Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Lavender Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria. Consumers should stop using the product.

    Product
    Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2014·2014-05-14

    Shimadzu Digital Radiography X-Ray System Recalled for Image Loss

    Shimadzu Medical Systems is recalling its Digital Radiography X-Ray System because a report was received regarding lost images under certain circumstances.

    Product
    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2014·2014-05-14

    Alere Triage BNP Test Recalled for Potential Out-of-Range Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage BNP Test because they may not recover within range when tested with certain controls.

    Product
    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2014·2014-05-14

    Mar Cor Purification Recalls Central Water Platform Reverse Osmosis Systems

    Mar Cor Purification is recalling 197 Central Water Platform (CWP) reverse osmosis systems because a specific lot of water inlet solenoid valves may fail, stopping water production.

    Product
    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1552-2014·2014-05-14

    Tenex TX1 Tissue Removal System Recalled for Packaging Defect

    Tenex Health Inc is recalling TX1 Tissue Removal Systems because cracks in the packaging may compromise the sterile barrier during transport in extreme cold.

    Product
    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1303-2014·2014-05-14

    Mangiacotti Lemon Verbena Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Lemon Verbena Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1300-2014·2014-05-14

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing at the nine-month time point.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1310-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially reducing product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1545-2014·2014-05-14

    Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status

    Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.

    Product
    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1313-2014·2014-05-14

    Boehringer Ingelheim Roxane Recalls Azathioprine Tablets Due to Incorrect Expiration Dates

    Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, because they were labeled with 36-month expiration dates instead of the approved 24 months.

    Product
    Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1309-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1311-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck is recalling Liptruzet tablets because outer packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1312-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Defective Outer Packaging

    Merck is recalling Liptruzet tablets because defective outer foil pouches may allow air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V244000·2014-05-13

    Supreme Corporation Recalls 2013 Transit Buses Due to Wheelchair Lift Fire Risk

    Supreme Corporation is recalling 116 model year 2013 transit buses and trolleys because an armored cable may not clear the wheelchair lift, posing a fire risk.

    Product
    STARTRANS — STARTRANS, SUPREME PRESIDENT, SENATOR II, ACTIVITY, SENATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V248000·2014-05-13

    Jerr-Dan Standard Duty Wreckers Recalled for Underlift Boom Drift

    Jerr-Dan is recalling 2007-2014 Standard Duty Wreckers because the underlift boom tilt cylinder may drift down during towing, increasing crash risk.

    Product
    JERR-DAN — JERR-DAN STANDARD DUTY WRECKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V243000·2014-05-13

    Pierce Recalls 2013 Vehicles Due to Seat Belt Buckle Defect

    Pierce Manufacturing is recalling 150 model year 2013 vehicles because seat belt buckles may fail to release, potentially hindering emergency egress.

    Product
    PIERCE — PIERCE DASH CF, ARROW XT, IMPEL, VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V249000·2014-05-13

    Seagrave Emergency Vehicles Recalled for Seat Belt Buckle Defect

    Seagrave is recalling 2013-2014 emergency vehicles because seat belt buckles may fail to release, hindering egress during emergencies.

    Product
    SEAGRAVE — SEAGRAVE TT06CX, XVOICS, TB50CO, TVOHCX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14175·2014-05-13

    Misty Mate Recalls Hand-Held Personal Misters Due to Laceration Risk

    Misty Mate is recalling about 9,000 hand-held personal misters sold at Hibbet Sports because the plastic cylinder can shatter, posing a laceration risk.

    Product
    Misty 2.5 High Pressure Personal Misters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14173·2014-05-13

    Paramount Trident UV Pool Sanitizers Recalled for Fire Hazard

    Paramount is recalling Trident Series 2 UV pool sanitizers because electrical arcing can cause the units to catch fire. Consumers should unplug the units and contact the manufacturer for a free replacement.

    Product
    Paramount Trident Series 2 (UV II) Ultraviolet Sanitation Systems for pools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14171·2014-05-09

    Coleman Recalls Northstar Liquid Fuel Lanterns Due to Fire Hazard

    Coleman is recalling Northstar liquid fuel lanterns because an incorrect gas feed tube can cause fuel leaks, posing fire and burn risks.

    Product
    Northstar® Liquid Fuel Lanterns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V240000·2014-05-08

    GM Recalls 2014 Buick Lacrosse and Chevrolet Malibu for Brake Defect

    General Motors is recalling 2014 Buick Lacrosse and Chevrolet Malibu vehicles because incorrect front brake rotors may cause brake pad detachment and reduced braking.

    Product
    CHEVROLET — CHEVROLET, BUICK MALIBU, LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14170·2014-05-08

    Classic Concepts Recalls Aman Trunks Due to Lead Paint Violation

    Classic Concepts is recalling Aman Trunks sold at Cost Plus World Market because the interior metal chains contain excessive lead, violating federal standards.

    Product
    Aman Trunk
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1269-2014·2014-05-07

    B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1276-2014·2014-05-07

    Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination

    Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1888-2014·2014-05-07

    Schwan's Recalls Holiday Foods Cold Canapes Due to Listeria Risk

    Schwan's Global Supply Chain is recalling Holiday Foods Gourmet Cold Canapes Assortment due to potential Listeria monocytogenes contamination from recalled ingredients.

    Product
    Holiday Foods Gourmet Cold Canapes Assortment, 4800361, UPC 70220748003616, 100 OCS. Keep Frozen, For Institutional Use Only, Defrost in Refrigerator for Approximately 3 hours Before Serving, Consume Immediately. Prepared by Holiday Foods Inc, Hollywood, Florida 33020.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-1277-2014·2014-05-07

    Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval

    Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/ANDA.

    Product
    Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1273-2014·2014-05-07

    B. Braun Recalls TrophAmine Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2014·2014-05-07

    B. Braun Recalls ProcalAmine Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling ProcalAmine injectable products due to visible particulate matter found in reserve samples.

    Product
    ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1272-2014·2014-05-07

    B. Braun Recalls 15% Amino Acids Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 15% Amino Acids Injection products due to visible particulate matter found in reserve sample units.

    Product
    15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1264-2014·2014-05-07

    B. Braun Recalls Cefoxitin and Dextrose Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Cefoxitin and Dextrose injectable products due to visible particulate matter found in reserve sample units.

    Product
    CEFOXITIN AND DEXTROSE — CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1266-2014·2014-05-07

    B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection due to visible particulate matter found in reserve sample units.

    Product
    Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1275-2014·2014-05-07

    B. Braun Recalls Hyperlyte CR Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling Hyperlyte CR injectable products because visible particulate matter was found in reserve sample units.

    Product
    Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2014·2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve sample units.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2014·2014-05-07

    Medisca Recalls Human Chorionic Gonadotropin Due to Labeling Error

    Medisca Inc. is recalling specific lots of Human Chorionic Gonadotropin (HCG) because the labels contain erroneous potency information.

    Product
    Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2014·2014-05-07

    John W Hollis Inc Recalls Polidocanol 3% Solution Due to Particulate Matter

    John W Hollis Inc is recalling 3 vials of Polidocanol 3% Solution due to the presence of particulate matter. The product was distributed in Missouri, Tennessee, Mississippi, and Wisconsin.

    Product
    Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1513-2014·2014-05-07

    Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error

    Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.

    Product
    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRA
    Category
    Medical Device
    Distribution
    7 states
  • SevereNHTSA·14V234000·2014-05-07

    Chrysler Recalls 2010-2014 Minivans for Vent Window Switch Fire Risk

    Chrysler is recalling 2010-2014 Town and Country and Grand Caravan minivans because the vent window switch may overheat and cause a vehicle fire.

    Product
    DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V235000·2014-05-07

    Fiat 500e Recall: Coolant Leak May Cause Loss of Propulsion

    Chrysler is recalling 2013-2014 Fiat 500e vehicles because a coolant leak in the power inverter module may cause a short circuit, leading to loss of propulsion and increased crash risk.

    Product
    FIAT — FIAT 500E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2014·2014-05-07

    B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter

    B. Braun Medical Inc. is recalling specific lots of Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide

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