The Recall Desk

Archive

August 2014 recalls

458 recalls were announced in August 2014.

What the numbers show

Critical
18
Severe
90
High
160
Moderate
169
Low
21

Of the 458 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

1–100 of 458

  • SevereNHTSA·14V519000·2014-08-28

    New Flyer Recalls 2014 Transit Buses Due to Fuel Filter Defect

    New Flyer is recalling 2014 transit buses because a fuel filter defect may cause the engine to stall without warning, increasing the risk of a crash.

    Product
    NEW FLYER — NEW FLYER XDE60, XDE40, XD60, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V518000·2014-08-28

    GM Recalls 2013-2014 Cadillac XTS and Chevrolet Impala for Air Bag Defect

    General Motors is recalling specific 2013-2014 Cadillac XTS and Chevrolet Impala vehicles because the air bag control module may be in manufacturing mode, preventing deployment in a crash.

    Product
    CADILLAC — CADILLAC, CHEVROLET XTS, IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V521000·2014-08-28

    Gillig Recalls 2014 Low Floor Buses Due to Fuel Filter Defect

    Gillig is recalling 231 model year 2014 Low Floor transit buses because a fuel filter defect may cause the engine to stall unexpectedly, increasing the risk of a crash.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14749·2014-08-28

    American Woodcrafters Recalls Bunk Beds Due to Fall Hazard

    American Woodcrafters is recalling about 1,900 Cottage Retreat II bunk beds sold at Havertys because side support rails can break, posing a fall hazard.

    Product
    Bunk beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2336-2014·2014-08-27

    Natural Grocers Recalls Energy Chunks Due to Salmonella Risk

    Natural Grocers by Vitamin Cottage is recalling Chunks of Energy products due to the potential presence of Salmonella.

    Product
    Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1550-2014·2014-08-27

    Baxter Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

    Baxter Healthcare is recalling 4,200 containers of 0.9% Sodium Chloride Injection because blue polyisoprene shavings were found inside the bag port tubes.

    Product
    0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1546-2014·2014-08-27

    Pharmacy Creations Recalls Ascorbic Acid Injection Vials Due to Mold Contamination

    Pharmacy Creations is recalling 70 vials of Ascorbic Acid 500 mg/mL sterile injection due to mold contamination. The affected product was distributed in New York, New Jersey, and Puerto Rico.

    Product
    Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Food)·F-2334-2014·2014-08-27

    Ciranda Organic Carob Powder Recalled Due to Salmonella Test

    Ciranda, Inc. is recalling one lot of Organic Carob Powder Light after a customer reported a positive Salmonella test.

    Product
    Ciranda Organic Carob Powder Light, Product Code 20030. Net Wt. 55.11 lbs / 25 kg. Ingredients: Organic Carob Powder. Manufactured in Italy.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-2333-2014·2014-08-27

    TJX Companies Recalls Ecoato Sweet Paprika Powder Due to Salmonella Risk

    The TJX Companies is recalling approximately 150 units of ecoato Sweet Paprika Powder because of a potential Salmonella contamination risk.

    Product
    Product is in a 160 gram, light green tin container, labeled in part: "ecoato Sweet Paprika Powder Product of Spain"
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1549-2014·2014-08-27

    Doctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin

    Doctor's Best is recalling Red Yeast Rice 1200 capsules because FDA analysis found undeclared lovastatin, making it an unapproved new drug.

    Product
    Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1555-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.

    Product
    fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, S
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2335-2014·2014-08-27

    Natural Grocers Recalls Organic Chunks of Energy Carob Supergreens for Salmonella Risk

    Natural Grocers by Vitamin Cottage is recalling Organic Chunks of Energy Carob Supergreens due to the potential presence of Salmonella.

    Product
    Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1547-2014·2014-08-27

    Hospira Recalls Propofol Vials Due to Metallic Particulate Matter

    Hospira Inc. is recalling 844,300 vials of Propofol Injectable Emulsion because glass defects allowed metallic particulates to enter the solution.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2256-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Su
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1553-2014·2014-08-27

    Healix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2254-2014·2014-08-27

    Ortho Development Recalls Knee Implant Components Due to Sealing Defects

    Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.

    Product
    Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2014·2014-08-27

    Ben Venue Recalls Cytarabine for Injection Due to Sterility Concerns

    Ben Venue Laboratories is recalling 7,172 vials of Cytarabine for Injection due to potential crimp defects that may affect sterility.

    Product
    CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1545-2014·2014-08-27

    Fresenius Kabi Recalls Propranolol Hydrochloride Injection Due to API Deficiencies

    Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.

    Product
    PROPRANOLOL — PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1554-2014·2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·14263·2014-08-27

    Goodman Recalls PTAC Units Due to Power Cord Fire and Burn Hazards

    Goodman Company is recalling approximately 233,500 packaged terminal air conditioners and heat pumps because power cords can overheat, posing fire and burn risks.

    Product
    Amana, Century, Comfort-Aire, Goodman and York International Packaged Terminal Air Conditioner/Heat Pump ("PTAC") units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2014·2014-08-27

    Tnuva USA Recalls Breaded Chicken Cutlets Due to Listeria Risk

    Tnuva USA is recalling approximately 8,316 pounds of Mom's Chicken Extra Thin Cutlets due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    New Jersey Firm Recalls Breaded Chicken Product For Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2261-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1551-2014·2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 50 fentanyl syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-2348-2014·2014-08-27

    Fish Family Farm and Shadow Valley Farm Milk Recalled for Peanut Contamination

    Fish Family Farm is recalling Grade A Whole Milk due to potential contamination with peanuts and pistachios. The products were sold in Connecticut and Massachusetts.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2340-2014·2014-08-27

    Renfro Foods Recalls XOCHITL Chipotle Queso Dip Due to Undeclared Wheat

    Renfro Foods is recalling XOCHITL Chipotle Queso Dip because a supplier mistakenly used wheat instead of whey in the cheese pre-mix, creating an undeclared allergen hazard.

    Product
    XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2342-2014·2014-08-27

    Renfro Foods Recalls Chile Con Queso for Undeclared Wheat

    Renfro Foods is recalling 16 oz. jars of Chile Con Queso because a supplier accidentally used wheat instead of whey in the cheese pre-mix.

    Product
    Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY STONEWALL KITCHEN; STONEWALL LANE, YORK MAINE 03909 USA 800-207-JAMS; STONEWALLKITCHEN.COM
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2259-2014·2014-08-27

    Medtronic Recalls Six Activa PC Implantable Neurostimulators

    Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

    Product
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2270-2014·2014-08-27

    Invivo Recalls Philips IP5 MRI Patient Monitoring Devices

    Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.

    Product
    Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2014·2014-08-27

    GE Healthcare Recalls Discovery XR656P/N Wall Stand Systems Due to Hook Failure

    GE Healthcare is recalling 334 Discovery XR656P/N wall stand systems because nylon hooks supporting the detector may fail, causing the detector to fall.

    Product
    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2258-2014·2014-08-27

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

    Product
    TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2341-2014·2014-08-27

    Renfro Foods Recalls XOCHITL Chipotle Queso Dip for Undeclared Wheat

    Renfro Foods is recalling XOCHITL Chipotle Queso Dip because a supplier accidentally used wheat instead of whey in the cheese pre-mix, creating an undeclared allergen.

    Product
    XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2014·2014-08-27

    ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals

    ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures

    Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

    Product
    6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-2338-2014·2014-08-27

    CaCoCo Superfood Drinking Chocolate Recalled for Potential Salmonella Contamination

    CaCoCo, Inc. is recalling specific lots of Superfood Drinking Chocolate because an organic ingredient used in the product is under recall for potential Salmonella contamination.

    Product
    CaCoCo Superfood Drinking Chocolate; Original - Flavor Melody: Sweet, Playful, Perfectly Spiced Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Butter, Maca, Coconut Crystal Sugar,Carob, Cacao Bean, Cacao Powder, Lucuma,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2337-2014·2014-08-27

    CaCoCo Superfood Drinking Chocolate Recalled for Potential Salmonella Contamination

    CaCoCo, Inc. is recalling specific lots of Superfood Drinking Chocolate because an organic ingredient used in the product is under recall for potential Salmonella contamination.

    Product
    CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet, Medicinal, Energizing Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Beans, Cacao Butter, Maca, Carob, coconut Crystal Sugar, Mesqui
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2301-2014·2014-08-27

    Zimmer Recalls Persona Knee System Trial Components Due to Breakage

    Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.

    Product
    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central ser
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-2344-2014·2014-08-27

    Brett Anthony Foods Recalls Sesame Ginger Dressing for Unlabeled Almond Allergen

    Brett Anthony Foods is recalling Sesame Ginger Dressing because almonds are not listed in the allergen warning statement despite being an ingredient.

    Product
    Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2148-2014·2014-08-27

    DePuy Synthes Recalls Craniomaxillofacial Distraction System Due to Reversal Risk

    Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.

    Product
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2014·2014-08-27

    Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk

    Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.

    Product
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2295-2014·2014-08-27

    ICU Medical Recalls Port Access Kits with Potential Sterility Issues

    ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

    Product
    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1542-2014·2014-08-27

    Baxter Recalls ProSol Amino Acid Injection Due to Particulate Matter

    Baxter Healthcare is recalling 6,204 bags of ProSol Amino Acid Injection because a retention sample contained particulate matter. The product was distributed nationwide.

    Product
    PROSOL — PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2346-2014·2014-08-27

    Fish Family Farm Milk Recalled for Potential Peanut and Pistachio Contamination

    Fish Family Farm is recalling Grade A 2% Reduced Fat Milk due to potential contamination with peanuts and pistachios. The products were distributed in Connecticut and Massachusetts.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2347-2014·2014-08-27

    Fish Family Farm Skim Milk Recalled for Peanut and Tree Nut Contamination

    Fish Family Farm is recalling Grade A Fat Free Skim Milk due to potential contamination with peanuts and pistachios.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighCPSC·14264·2014-08-27

    NRS Recalls Water Sports Helmets Due to Chin Strap Rivet Failure Risk

    NRS is recalling about 3,300 water sports helmets because rivets holding the chin strap can fail, posing a risk of head injury. No injuries have been reported.

    Product
    NRS water sports helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2345-2014·2014-08-27

    Fish Family Farm Chocolate Milk Recalled for Peanut and Tree Nut Contamination

    Fish Family Farm is recalling 92 half-gallons of Shadow Valley Farm brand chocolate milk due to potential contamination with peanuts and pistachios.

    Product
    FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2253-2014·2014-08-27

    Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects

    Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.

    Product
    Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14748·2014-08-27

    Sunjoy Multi-Purpose Outdoor Shelters Recalled for Fire Hazard

    Sunjoy is recalling about 2,000 multi-purpose outdoor shelters sold at BJ's Wholesale Club because the fabric canopy fails to comply with a voluntary flammability standard, posing a fire hazard.

    Product
    Multi-Purpose Outdoor Shelter
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 units of Persona Tibial General Instrument Trays because incorrect bracket geometry may prevent proper sterilization of surgical instruments.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central ser
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2299-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2014·2014-08-27

    ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

    ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.

    Product
    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2014·2014-08-27

    Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk

    Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.

    Product
    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2245-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.

    Product
    Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2257-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches

    Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.

    Product
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Components Due to Breakage Complaints

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2014·2014-08-27

    Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues

    Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.

    Product
    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2014·2014-08-27

    FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining

    Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.

    Product
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2238-2014·2014-08-27

    Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results

    Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.

    Product
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2271-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2269-2014·2014-08-27

    Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales

    Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.

    Product
    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2281-2014·2014-08-27

    AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2276-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2272-2014·2014-08-27

    AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal foldab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2287-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal folda
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2268-2014·2014-08-27

    Ansar ANX-3.0 Autonomic Monitor Blood Pressure Circuit Recall

    Ansar Group is recalling 351 ANX-3.0 Autonomic Monitor systems because the blood pressure circuit may fail to inflate the cuff or activate, resulting in no blood pressure measurement.

    Product
    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1548-2014·2014-08-27

    US Compounding Recalls Mislabeled Ephedrine Sulfate Injection Syringes

    US Compounding Inc is recalling 762 syringes of ephedrine sulfate injection due to a labeling error on the outer protective bags that could cause confusion regarding the drug's strength.

    Product
    ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2014·2014-08-27

    AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2014·2014-08-27

    AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1541-2014·2014-08-27

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failures

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing. The recall covers 11,661 bottles distributed nationwide.

    Product
    Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2282-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2014·2014-08-27

    AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2274-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal foldab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2277-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5, 16.0 Product Usage: AMO TECNIS CL monofocal foldable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 intraocular lenses that may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL monofoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2266-2014·2014-08-27

    Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling

    Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.

    Product
    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2244-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.

    Product
    Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Food)·F-2343-2014·2014-08-27

    American Spoon Foods Recalls Sour Cherry Marmalade Due to Mold

    American Spoon Foods is recalling 682 jars of Sour Cherry Marmalade because the product may contain mold. Consumers should check their pantries for the specific lot numbers listed.

    Product
    American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Total package size (e.g. 12 packages per case): 12 jars per case
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2248-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.

    Product
    6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2249-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

    Product
    6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2250-2014·2014-08-27

    Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.

    Product
    4.5 mm Malleolar Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Food)·F-2330-2014·2014-08-27

    Jody's Freedom Funfetti Recalled for Undeclared Food Dyes

    Jody's Inc. is recalling Freedom Funfetti candy because it contains undeclared food dyes Blue #1, Blue #2, and Red #40.

    Product
    Jody's, Freedom Funfetti; Net Wt 7.5 oz (213 g) in clear cellophane bag.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2251-2014·2014-08-27

    Zimmer Recalls 4.0 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.

    Product
    4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Food)·F-2331-2014·2014-08-27

    Jody's Kettle Corn Recalled for Undeclared Red Color Additive

    Jody's Inc. is recalling 144 bags of Breast Cancer Awareness Kettle Corn due to the presence of undeclared Red #3 dye.

    Product
    Jody's, Breast Cancer Awareness Kettle Corn; Net Wt 3oz in clear cellophane bag.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2263-2014·2014-08-27

    Biolase Recalls WaterLase iPlus Dental Laser Systems Due to Software Error

    Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.

    Product
    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal fol
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.