The Recall Desk

Archive

August 2015 recalls

585 recalls were announced in August 2015.

What the numbers show

Critical
75
Severe
90
High
176
Moderate
225
Low
19

Of the 585 recalls this month scored against our rubric, 13% are Critical, 15% are Severe.

101–200 of 585

  • HighFDA (Devices)·Z-2398-2015·2015-08-26

    Winco Designer Care Cliner chairs recalled for non-compliant foam

    Winco Mfg., LLC is recalling two Designer Care Cliner chairs because the foam used was not fire retardant as required.

    Product
    Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2015·2015-08-26

    Winco Care Cliner Standart Steel Casters Recalled for Fire Hazard

    Winco Mfg., LLC is recalling Care Cliner Standart chairs because the foam used was not fire retardant as required.

    Product
    Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2985-2015·2015-08-26

    Inventure Foods Recalls Frozen Butter Beans Due to Listeria Risk

    Inventure Foods is recalling specific packages of frozen speckled butter beans due to potential Listeria contamination from GMP violations.

    Product
    Fresh Frozen Grade A Speckled Butter Beans, Net Wt. 32 oz. (2 lb.) 907 g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20000-1; Fresh Frozen Grade A Specked Butter Beans, Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549,U
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2362-2015·2015-08-26

    CareFusion Alaris Syringe Pump Recall for Unresponsive Control Defect

    CareFusion 303, Inc. is recalling Alaris Syringe Pumps, Model 8110, because they may become unresponsive to key presses after a channel error is cleared.

    Product
    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2015·2015-08-26

    Teleflex Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes Due to Connector Cracking

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2395-2015·2015-08-26

    Winco Drop Arm Care Cliner Chairs Recalled for Fire Hazard

    Winco Mfg. is recalling 30 Drop Arm Care Cliner chairs because the foam used was not fire retardant as required.

    Product
    Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2015·2015-08-26

    Cordis RenLane Renal Denervation Catheter Recalled for Potential Tip Damage

    Cordis is recalling 98 RenLane Renal Denervation Catheters because the helical tip may be damaged if the arterial access device valve is not fully open.

    Product
    RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·114-2015·2015-08-26

    California Qi Li's Recalls Duck Products Due to Undeclared Allergens

    California Qi Li's Braised Chicken is recalling approximately 6,644 pounds of duck head and neck products because they contain undeclared soy and wheat allergens.

    Product
    California Qi Li's Braised Chicken Recalls Duck Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2964-2015·2015-08-26

    Freedom Snacks Sea Salt Caramel Popcorn Recalled for Undeclared Milk

    Freedom Snacks is recalling 50 bags of Sea Salt Caramel Gourmet Popcorn because milk is not declared on the label, posing a risk to consumers with milk allergies.

    Product
    Sea Salt Caramel Gourmet Popcorn, sold under brand Freedom Snacks, packaged in a flexible plastic bag, net wt. 10 oz.. There is NO UPC. The product is labeled in parts: "***FREEDOM SNACKS***SEA SALT CARAMEL Gourmet Popcorn***Ingredients: popcorn, sugar, brown sugar, corn syru
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2329-2015·2015-08-26

    FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects

    The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.

    Product
    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2963-2015·2015-08-26

    Freedom Snacks Recalls Caramel Popcorn for Undeclared Milk

    Freedom Snacks is recalling 50 bags of Classic Caramel Gourmet Popcorn sold in Washington due to undeclared milk.

    Product
    Classic Caramel Gourmet Popcorn, sold under brand Freedom Snacks, packaged in a flexible plastic bag, net wt. 10 oz.. There is NO UPC. The product is labeled in parts: "***FREEDOM SNACKS***CLASSIC CARAMEL Gourmet Popcorn***Ingredients: popcorn, brown sugar, sugar, corn syrup,
    Category
    Food
    Distribution
    1 state
  • HighCPSC·15225·2015-08-26

    CAMP USA Recalls Blade Runner Crampons Due to Fall Hazard

    CAMP USA is recalling Cassin Blade Runner and Alpine crampons because the front part can break, posing a fall hazard. No injuries have been reported.

    Product
    Cassin Blade Runner and Blade Runner Alpine Crampons
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2015·2015-08-26

    American Science & Engineering Recalls Gemini Cabinet X-ray Systems

    American Science & Engineering is recalling 125 Gemini Cabinet X-ray systems because a fault may cause X-rays to be produced without the indicator lights illuminating.

    Product
    American Science & Engineering Inc,Gemini Cabinet X-ray system.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2423-2015·2015-08-26

    International Biophysics Recalls IBC Aortic Punch Due to Seal Issues

    International Biophysics Corp. is recalling 10,330 units of IBC Aortic Punch because the heat seal on sterile pouches may not meet strength acceptance criteria.

    Product
    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15226·2015-08-26

    CAMP USA Recalls Tour Nanotech Crampons Due to Fall Hazard

    CAMP USA is recalling Tour Nanotech Automatic and Semi-Automatic crampons because the heel bail can detach, posing a fall hazard. No injuries have been reported.

    Product
    Tour Nanotech Automatic and Semi-Automatic Crampons
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15227·2015-08-26

    Bosch Recalls Dremel Rotary Tools Due to Overheating and Burn Risk

    Robert Bosch Tool is recalling Dremel MICRO Model 8050 rotary tools because the circuit board can overheat, melt the enclosure, and cause burns.

    Product
    Dremel® MICRO™ Model 8050 Rotary Tool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2015·2015-08-26

    Winco XL Convalescent Recliner Recalled for Fire Safety Defect

    Winco Mfg. is recalling XL Convalescent Recliners because the foam used was not fire retardant as required.

    Product
    Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2015·2015-08-26

    Winco Patient Recliner Recalled for Non-Fire-Retardant Foam

    Winco Mfg. is recalling specific patient recliners because the foam used was standard foam rather than fire-retardant foam, failing to meet safety standards.

    Product
    Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2015·2015-08-26

    Teleflex Recalls Tracheopart Sets Due to Connector Detachment

    Teleflex is recalling sterile Tracheopart Sets because the cobb connector may detach from the main connector before use.

    Product
    Tracheopart Set (Left), Sterile
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2390-2015·2015-08-26

    Sedecal RadPro 40kW Digital X-Ray Panel Recalled for Uncontrolled Movement Risk

    Sedecal S.A. is recalling RadPro 40kW Digital X-Ray systems because electrostatic energy may cause uncontrolled movements that could bump into users or patients.

    Product
    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and ot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2015·2015-08-26

    Winco Drop Arm Care Cliner Chairs Recalled for Fire Hazard

    Winco Mfg. is recalling three Drop Arm Care Cliner chairs because the foam used was not fire retardant as required.

    Product
    Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2015·2015-08-26

    Stryker Recalls Wrist Implants Due to Potential Sterile Barrier Compromise

    Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.

    Product
    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2400-2015·2015-08-26

    Winco Elite Care Chairs Recalled for Fire Retardant Foam Mislabeling

    Winco Mfg. is recalling 32 Elite Care chairs because foam shipped as fire retardant was actually standard foam, failing safety standards.

    Product
    Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2015·2015-08-26

    Siemens Symbia S Series Nuclear Medicine Imaging Systems Recalled for Overheating Risk

    Siemens is recalling Symbia S Series nuclear medicine imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2413-2015·2015-08-26

    Teleflex Recalls Tracheopart Sets Due to Connector Detachment

    Teleflex is recalling sterile Tracheopart Sets because the cobb connector may detach from the main connector before use.

    Product
    Tracheopart Set (Right), Sterile
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2402-2015·2015-08-26

    Winco Inverness Recliners Recalled for Fire Retardant Foam Mislabeling

    Winco Mfg. is recalling 29 Inverness recliners because the foam was mislabeled as fire retardant but is actually standard foam.

    Product
    Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2975-2015·2015-08-26

    Crystal Farms Shredded Hash Browns Recalled for Golf Ball Slivers

    Michael Foods is recalling Crystal Farms Shredded Hash Browns because the product may contain small slivers of shredded golf ball.

    Product
    Crystal Farms Simply Potatoes Shredded Hash Browns packaged as individual plastic bags Net Wt. 20 oz (1 lb 4 oz) 567 g; UPC 0 20169 22233 4. The 20 oz containers are packed 12 per case (15 lbs total weight); UPC 2 00 20169 22233 8. Distributed by Crystal Farms, Minnetonka, MN.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2015·2015-08-26

    Teleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment

    Teleflex is recalling Bronchial One Lumen Tubes - Left because customer complaints reported the cobb connector detaching from the main connector prior to use.

    Product
    Bronchial One Lumen Tube - Left
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-2976-2015·2015-08-26

    Friendly's Vienna Mocha Chunk Ice Cream Recalled for Foreign Object

    Friendly Ice Cream Corp. is voluntarily recalling 20,736 tubs of Vienna Mocha Chunk Ice Cream due to the potential presence of a foreign object.

    Product
    Friendly's Vienna Mocha Chunk Ice Cream Tub, 48 U.S. FL. OZ. UPC: 0-29839 00557-4
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2394-2015·2015-08-26

    Winco Care Cliner Chairs Recalled for Non-Fire-Retardant Foam

    Winco Mfg. is recalling four Care Cliner X-Large chairs because the foam used was standard foam rather than fire-retardant foam.

    Product
    Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2999-2015·2015-08-26

    Inventure Foods Recalls Frozen Okra Due to Listeria Contamination Risk

    Inventure Foods is recalling specific sizes of frozen whole okra due to a risk of Listeria contamination caused by GMP violations.

    Product
    Fresh Frozen Grade A Whole Okra, Net Wt. 32 Oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20350-7, Fresh Frozen Grade A Whole Okra, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, Fresh Frozen Whole Okr
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2401-2015·2015-08-26

    Winco Elite Care Chairs Recalled for Non-Fire Retardant Foam

    Winco Mfg. is recalling 27 Elite Care chairs because the foam used was not fire retardant as required.

    Product
    Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2970-2015·2015-08-26

    HEB Wheat Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling specific wheat buns that may contain cotton fibers. Consumers in Texas should check their pantries.

    Product
    Good Bread 16 Wheat Buns, Net Wt. 29.4 oz (832g); HEB Bake Shop 8 Wheat Hamburger Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220191642
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2969-2015·2015-08-26

    HEB Seeded Hamburger Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling specific lots of HEB Bake Shop seeded hamburger buns because they may contain cotton fibers.

    Product
    HEB Bake Shop 8 Seeded Hamburger Buns Enriched Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220101276; HEB Bake Shop 6 Texas Sized Seeded Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220217618
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2427-2015·2015-08-26

    Stryker Recalls uHead and Other Ulnar Implants Due to Packaging Concerns

    Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.

    Product
    uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2396-2015·2015-08-26

    Winco Drop Arm Care Cliner Chairs Recalled for Fire Retardant Mislabeling

    Winco Mfg., LLC is recalling Drop Arm Care Cliner chairs because the foam was mislabeled as fire retardant but is actually standard foam.

    Product
    Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2386-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters

    C.R. Bard is recalling 37,686 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2430-2015·2015-08-26

    Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns

    Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.

    Product
    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2388-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters for Sterile Breach

    C.R. Bard is recalling 534,972 Magic3 Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2015·2015-08-26

    Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

    Product
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2424-2015·2015-08-26

    International Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues

    International Biophysics Corp. is recalling 771 IBC Vascular Loops because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2972-2015·2015-08-26

    Hill Country Fare Hot Dog Buns Recalled for Cotton Fibers

    H E B Grocery Company is recalling Hill Country Fare and HEB Bake Shop hot dog buns because they may contain cotton fibers.

    Product
    Hill Country Fare 16 Hot Dog Buns Enriched Buns, Net Wt. 24 OZ (1 LB 8 OZ) (680g). UPC: 04122041611; Hill Country Fare 8 Hot Dog Buns Enriched Buns, Net Wt. 12 OZ (340g), UPC: 041220602018; HEB Bake Shop 8 White Hot Dog Buns Enriched Buns, Net Wt. 12 OZ, UPC: 041220839100
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2973-2015·2015-08-26

    H E B Recalls Good Bread Hot Dog Buns for Cotton Fiber Contamination

    H E B Grocery Company is recalling specific Good Bread hot dog buns because they may contain cotton fibers. The affected products were distributed in Texas.

    Product
    Good Bread 10" Coney, Net Wt. 18.2 OZ (516g), UPC: 041220181506; Good Bread 16 Hot Dog Enriched Buns Net Wt. 24 oz (680g) UPC: 04122018147
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2428-2015·2015-08-26

    Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.

    Product
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2387-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling specific lots of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2015·2015-08-26

    Radiometer Fixation Kit N20 Recalled for Paper Coating Transfer

    Radiometer America Inc is recalling Fixation Kit N20 units because paper liner coating may stick to the fixation ring.

    Product
    Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The T
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2389-2015·2015-08-26

    Stryker Triathlon X3 Tibial Bearing Insert Recall Due to Labeling Error

    Stryker is recalling 10 units of Triathlon X3 Tibial Bearing Inserts because one unit was found in a pack labeled for a different model.

    Product
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2421-2015·2015-08-26

    Trilliant Surgical Recalls Non-Sterile Cannulated Screw Countersinks

    Trilliant Surgical Ltd. is recalling 102 units of non-sterile cannulated screw countersinks because their cutting efficiency was out of specification.

    Product
    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2974-2015·2015-08-26

    HEB Wheat Hot Dog Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company is recalling HEB Bake Shop 8 Wheat Hot Dog Buns because they may contain cotton fibers. The recall covers 1,727 units distributed in Texas.

    Product
    HEB Bake Shop 8 Wheat Hot Dog Buns, Net Wt. 12 OZ, UPC: 041220191659
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2416-2015·2015-08-26

    Siemens ADVIA Chemistry Acetaminophen Reagents Recalled for NAC Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Acetaminophen reagents due to a change in N-acetylcysteine concentration that may cause assay interference.

    Product
    ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2015·2015-08-26

    C.R. Bard Recalls Magic3 Intermittent Urinary Catheters Due to Sterile Breach

    C.R. Bard is recalling 91,140 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2404-2015·2015-08-26

    Siemens Artis zee/zeego Systems Recalled for X-ray Locking Function Defect

    Siemens Medical Solutions is recalling 586 Artis zee/zeego angiography systems because a system error could prevent users from exiting the X-ray locking function without a restart.

    Product
    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1347-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1346-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2384-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling 14,310 units of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2343-2015·2015-08-26

    Draeger Evita Infinity V500 Ventilator Battery Recall

    Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

    Product
    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1348-2015·2015-08-26

    UCB Recalls Univasc Tablets Due to Failed Dissolution Testing

    UCB, Inc. is recalling Univasc (moexipril HCl) tablets because they failed 24-month dissolution testing. The recall covers 2,916 bottles distributed nationwide.

    Product
    univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2015·2015-08-26

    Veridex Recalls Cell Search Circulating Tumor Kits Due to Artifacts

    Veridex, LLC is recalling 1,560 Cell Search Circulating Tumor Kits due to the presence of artifacts and control failures.

    Product
    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2015·2015-08-26

    Synthes Medical Nail Wraps Recalled for Insufficient Multi-Use Testing

    Synthes (USA) Products LLC is recalling specific tibial and intramedullary nail wraps because they lack sufficient testing to be considered multi-use items.

    Product
    Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail dur
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2968-2015·2015-08-26

    HEB Bake Shop Hamburger Buns Recalled for Potential Cotton Fiber Contamination

    H E B Grocery Company, LP is recalling specific HEB Bake Shop hamburger buns because they may contain cotton fibers. The recall covers 4,540 units distributed in Texas.

    Product
    HEB Bake Shop 8 Hamburger, Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 04122041461; HEB Bake Shop 6 Texas Sized Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220742264; Kurz Texas Size Plain Buns (no label)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2422-2015·2015-08-26

    International Biophysics Recalls IBC Suction Wands Due to Seal Defects

    International Biophysics Corp. is recalling 100 IBC Suction Wands because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2971-2015·2015-08-26

    HEB Bake Shop Whole Wheat Hamburger Buns Recalled for Cotton Fibers

    H E B Grocery Company is recalling 653 units of HEB Bake Shop 100% Whole Wheat Hamburger Buns because they may contain cotton fibers.

    Product
    HEB Bake Shop 100% Whole Wheat 8 Hamburger Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220830565
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2420-2015·2015-08-26

    Medtronic EOPA Arterial Cannula Recalled for Missing Guidewire

    Medtronic is recalling EOPA Arterial Cannulas (Lot 2015060544) because they were shipped without the required guidewire.

    Product
    Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1350-2015·2015-08-26

    Qualitest Recalls Ampicillin Capsules Due to Unapproved Labeling

    Vintage Pharmaceuticals LLC is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg, because they are labeled with unapproved labeling.

    Product
    AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1345-2015·2015-08-26

    Sun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed to meet drug release specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2434-2015·2015-08-26

    BD Vacutainer SST Plus Blood Collection Tubes Recalled for Stopper Defects

    Becton Dickinson & Company is recalling specific lots of BD Vacutainer SST Plus Blood Collection Tubes because some stoppers were manufactured with a reduced cycle cure time.

    Product
    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2432-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.

    Product
    Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2431-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.

    Product
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2419-2015·2015-08-26

    Getinge 86 Series Washer/Disinfector Recalled for Remote Access Vulnerability

    Getinge Disinfection AB is recalling 20 Model 8666 and 8668 washer/disinfectors due to a potential for unauthenticated remote network access.

    Product
    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
    Category
    Medical Device
    Distribution
    12 states
  • SevereCPSC·15749·2015-08-25

    Cybex Recalls Arm Curl Machines Due to Impact Injury Hazard

    Cybex International is recalling about 4,400 arm curl machines because swivel handles can break off, posing an impact injury hazard to users.

    Product
    Arm Curl Machines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15222·2015-08-25

    Scag Liberty-Z Lawn Mowers Recalled for Gas Tank Fire Hazard

    Scag Power Equipment is recalling about 4,400 Liberty-Z zero-turn lawn mowers because the gas tank can leak, posing a fire hazard. No injuries have been reported.

    Product
    Scag Liberty-Z zero-turn lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·113-2015·2015-08-25

    Kraft Heinz Recalls Turkey Bacon Products Due To Possible Adulteration

    Kraft Heinz is recalling approximately 2.1 million pounds of Oscar Mayer turkey bacon products that may spoil before their expiration dates.

    Product
    Kraft Heinz Foods Company — Kraft Heinz Foods Company Recalls Turkey Bacon Products Due To Possible Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V538000·2015-08-24

    McNeilus Recalls 2014-2015 CNG Trucks Due to Pressure Relief Defect

    McNeilus is recalling 2014-2015 CNG Refuse and Concrete trucks because pressure relief devices may fail to vent pressure, increasing the risk of tank explosion, fire, and injury.

    Product
    MCNEILUS — MCNEILUS CNG REFUSE TRUCK, CNG CONCRETE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V539000·2015-08-24

    East Manufacturing Recalls 2014-2016 Trailers Due to Wheel Bearing Fire Risk

    East Manufacturing is recalling 2014-2016 trailers because insufficient grease in wheel hubs may cause overheating, leading to fire or wheel detachment.

    Product
    EAST MANUFACTURING — EAST MANUFACTURING FRAME GENESIS TRAILER, DUMP TRAILER, FRAMELESS GENESIS TRAILER, REFUSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V537000·2015-08-24

    BMW Recalls 2013-2015 G 650 GS Motorcycles for Stalling Risk

    BMW is recalling 1,060 G 650 GS and G 650 GS Sertao motorcycles because they may stall while idling with the clutch pulled in, increasing crash risk.

    Product
    BMW — BMW G 650 GS SERATO, G 650 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V535000·2015-08-21

    Strick Van Trailer Recall for Suspension Pivot Bolt Failure Risk

    Strick is recalling 2014 Van Trailers with SAF-Holland suspension systems because pivot bolts may fail, potentially causing the axle to separate from the trailer.

    Product
    STRICK — STRICK VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V534000·2015-08-21

    Chrysler Recalls 2014-2015 Ram 1500 Trucks for Side Air Bag Defect

    Chrysler is recalling 2014-2015 Ram 1500 Quad Cab trucks because side air bag curtains may not fully overlap the C-pillars, increasing injury risk in crashes.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E068000·2015-08-21

    Ricon wheelchair lifts recalled due to potential platform failure

    Ricon is recalling specific wheelchair lifts because oversized pivot holes may allow bearings to shift, potentially causing the platform to fall out of the vehicle.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V532000·2015-08-20

    Oshkosh Recalls 2014-2015 S-Series Concrete Mixers Due to Pressure Relief Defect

    Oshkosh is recalling 2014-2015 S-Series concrete mixers powered by compressed natural gas because pressure relief devices may fail to vent pressure, posing a risk of tank explosion, fire, and injury.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E067000·2015-08-20

    Reyco Granning Recalls Independent Front Suspension Assemblies for Loose Ball Joints

    Reyco Granning is recalling Independent Front Suspension assemblies manufactured between April 2011 and February 2015 due to loose ball joints that could separate and cause a loss of steering control.

    Product
    SUSPENSION:FRONT:CONTROL ARM:LOWER BALL JOINT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V533000·2015-08-20

    Ford Recalls F-650 and F-750 Trucks for Seat Belt Anchor Defect

    Ford is recalling 2011-2013 and 2015 F-650 and F-750 trucks because passenger seat belt anchors may be installed in the wrong location, increasing injury risk in a crash.

    Product
    FORD — FORD F-650 SD, F-750 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1328-2015·2015-08-19

    Methotrexate Injection Recalled Due to Presence of Particulate Matter

    Mylan Institutional LLC is recalling Methotrexate Injection vials due to the presence of particulate matter.

    Product
    Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Ro
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2961-2015·2015-08-19

    Bella Rosa Grated Parmesan Cheese Recalled for Undeclared Egg Lysozyme

    Arthur Schuman Inc. is recalling Bella Rosa Grated Parmesan Cheese because it may contain undeclared egg lysozyme, a potential allergen.

    Product
    Bella Rosa Parmesan Net Wt. 20 oz (567 g) 1.25 LB Arthur Schuman, Inc. Fairfield, NJ 07064 UPC 088231410041
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2960-2015·2015-08-19

    Patel Grocery Coriander Powder Recalled for Undeclared Peanut Allergen

    Patel Grocery Corp is recalling America's Best Coriander Powder in New York due to undeclared peanut allergens.

    Product
    AMERICA'S BEST CORRIANDER POWDER, NET WT.: 1) 7 OZ, 2) 14 OZ. (400 GMS) and 3) 28 OZ, sealed in plastic bags, Packed by Patel Grocery 5303 4th Ave. Brooklyn, NY 11220
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·15748·2015-08-19

    Grizzly Recalls 10-Inch Hybrid Table Saws Due to Laceration Hazards

    Grizzly Industrial is recalling 10-inch hybrid table saws because a loose motor pulley can strike the blade, causing metal fragments to fly and injure users.

    Product
    Grizzly 10-inch hybrid table saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1329-2015·2015-08-19

    Mylan Recalls Cytarabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling 8,340 vials of Cytarabine Injection due to the presence of particulate matter. The affected product was distributed nationwide.

    Product
    Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2358-2015·2015-08-19

    Invacare Pronto Air Power Wheelchair Recall for Battery Overheating Risk

    Invacare is recalling 1,057 Pronto Air power wheelchairs because the batteries may overheat during charging, posing risks of chemical burns and property damage.

    Product
    Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2015·2015-08-19

    Fresenius Medical Care Recalls Naturalyte Liquid Bicarbonate Concentrate

    Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. The recall covers 2,264,028 units distributed nationwide.

    Product
    Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
    Category
    Medical Device
    Distribution
    Distributed nationwide

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