The Recall Desk

Archive

November 2017 recalls

629 recalls were announced in November 2017.

What the numbers show

Critical
72
Severe
168
High
284
Moderate
80
Low
25

Of the 629 recalls this month scored against our rubric, 11% are Critical, 27% are Severe.

1–100 of 629

  • SevereNHTSA·17V769000·2017-11-30

    Hyundai Recalls 2013-2014 Elantra for Brake Pedal Stopper Pad Defect

    Hyundai is recalling 2013-2014 Elantra vehicles because a deteriorating brake pedal stopper pad can cause brake lights to stay on and allow shifting out of park without pressing the brake pedal.

    Product
    HYUNDAI — HYUNDAI ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18050·2017-11-30

    Flos Recalls Pendant Light Fixtures Due to Impact Injury Hazard

    Flos Inc. is recalling specific Romeo Moon and Romeo Louis II pendant light fixtures because the internal glass diffuser can detach and fall, posing an impact injury hazard.

    Product
    Pendant light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18049·2017-11-30

    Synodrin Pain Relieving Cream Recalled for Non-Child-Resistant Packaging

    Natural Solutions for Life is recalling Synodrin Pain Relieving Cream because the jar caps are not child-resistant, posing a poisoning risk to young children.

    Product
    Maximum Strength Synodrin Pain Relieving Cream with Lidocaine
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0362-2018·2017-11-29

    Paragon Broccoli Florets Recalled for Potential Listeria Contamination

    Paragon Wholesale Foods is recalling specific lots of broccoli florets due to potential Listeria monocytogenes contamination linked to a supplier recall.

    Product
    Paragon Wholesale Foods, Warrendale, PA 15086 Label: Paragon; Best if used by 10/16/17; Broccoli Florets 1/2 Cup 50/1.7 oz.; X0011932 17279; UPC: 86870 03200 AND Paragon; Best if used by: 10/23/17; Broccoli Florets 1/2 Cup 50/1.7 oz.; X0012592 17286; UPC: 86870 03200 Bul
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0141-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 537 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0137-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 720 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0143-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 333 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0135-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech, Inc. is recalling 733 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereNHTSA·17V768000·2017-11-29

    Ford Recalls 2017 F-53 and F-59 Chassis for Brake Fluid Leak Risk

    Ford is recalling 2017 F-53 and F-59 chassis because missing plugs in the brake control unit may cause fluid leaks or air ingestion, increasing stopping distance.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0132-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 665 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0160-2018·2017-11-29

    FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure

    The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.

    Product
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0167-2018·2017-11-29

    Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors

    Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.

    Product
    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0126-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 57 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0144-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0072-2018·2017-11-29

    Spacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures

    Spacelabs Healthcare is recalling 110 Arkon Anesthesia Workstations due to failures in ventilation, gas delivery, and display alarms.

    Product
    Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V766000·2017-11-29

    Volkswagen Recalls 2018 Atlas Vehicles Due to Fuel Tank Leak Risk

    Volkswagen is recalling 2018 Atlas vehicles because the fuel tank may have insufficient wall thickness, potentially causing a fuel leak and increasing fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0368-2018·2017-11-29

    Icybay Brand Frog Legs Recalled for Unapproved Antibiotics

    Slade Gorton & Company is recalling Icybay Brand Frog Legs due to the presence of unapproved antibiotics, nitrofurans and chloramphenicol.

    Product
    Icybay Brand Frog Legs, 4/6 Ct / Lb Farm Raised Trimmed, Frozen. 30 lb. Master Carton (5 lb. inner boxes 6 boxes per master case) UPC Codes: 073129282770
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0140-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 547 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0117-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0139-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 573 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0125-2018·2017-11-29

    Halyard Health Recalls NOVAPLUS Endotracheal Suction Kits Due to Leaking Vials

    Halyard Health is recalling NOVAPLUS Endotracheal WET PAK Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0145-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighNHTSA·17V767000·2017-11-29

    Ford Recalls 2016 Explorer and F-150 for Seat Bolt Defect

    Ford is recalling 2016 Explorer and F-150 vehicles because loose seat bolts may cause cushions to detach in a crash, increasing injury risk.

    Product
    FORD — FORD EXPLORER, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 198 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0127-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 109 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0122-2018·2017-11-29

    Halyard Closed Suction System Recalled Due to Saline Vial Leaking Risk

    Halyard Health is recalling specific lots of Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0335-2018·2017-11-29

    Shoreline Fruit Recalls Dark Chocolate Covered Cherries for Undeclared Milk

    Shoreline Fruit is voluntarily recalling dark chocolate covered cherry products due to undeclared milk in the dark chocolate coating.

    Product
    Dried Dark Chocolate Covered Cherries, The products are packaged in 25-pound corrugated boxes and 6 oz. and 24 oz. stand-up pouch packaging.
    Category
    Food
    Distribution
    47 states
  • HighFDA (Devices)·Z-0110-2018·2017-11-29

    Medtronic MiniMed Mio Infusion Sets Recalled for Potential Insulin Over-Delivery

    Medtronic is recalling MiniMed Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0159-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 678 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0337-2018·2017-11-29

    Astor Chocolate Recalls Dark Chocolate Covered Cranberries for Undeclared Milk

    Astor Chocolate Corporation is recalling Dark Chocolate Covered Cranberries due to an undeclared milk allergen. The product was distributed across multiple US states and Canada.

    Product
    Astor Chocolate Corporation Brand Dark Chocolate Covered Cranberries in Astor or Customer Logo packaging a. 1 oz. giveaway type package sizing b. 4 oz. giveaway type package sizing c. No best by date on units d. Individual cases sold to Astor branded customers i. Case c
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0332-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Almonds for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Turbinado Sea Salt Almonds because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Turbinado Sea Salt Almonds , 15 lbs., 10 lbs., 18/14 oz.,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0320-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Coconut Almonds for Undeclared Milk

    GKI Foods is voluntarily recalling specific lots of Dark Chocolate Coconut Almonds because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Coconut Almonds, 10 lbs., 15 lbs., 25 lbs.
    Category
    Food
    Distribution
    21 states
  • HighCPSC·18046·2017-11-29

    Libbey Recalls Bourbon Taster Glasses Due to Laceration Hazard

    Libbey Glass is recalling approximately 229,000 Bourbon Taster Glasses because they can break during normal use, posing a laceration hazard.

    Product
    Bourbon Taster Glasses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2018·2017-11-29

    Abbott Peristaltic Head Tubing Recalled for Potential Leaking

    Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.

    Product
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0164-2018·2017-11-29

    Medline Transfer/Gait Belt Recall Due to Locking Mechanism Failure

    Medline Industries is recalling 1,428 Transfer/Gait Belts because the locking mechanism may fail to secure the strap, allowing it to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility

    Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0329-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Raisins Due to Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Raisins because they may contain an undeclared milk allergen. The recall covers multiple lot sizes and distribution states.

    Product
    Dark Chocolate Raisins, 5 lbs., 10 lbs., 15 lbs., 25 lbs., 20 lbs., 30 lbs.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0130-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 207 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0119-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Potential Leaking

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0142-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 311 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0106-2018·2017-11-29

    ICU Medical Recalls IV Sets with Potential Metallic Burrs in Stopcocks

    ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.

    Product
    SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rota
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0416-2018·2017-11-29

    Rich Products Recalls Mislabeled Macadamia Nut Cookie Dough

    Rich Products Corp is recalling Brewhouse Macadamia Nut Cookie Dough because it is mislabeled and actually contains peanut butter cookie dough.

    Product
    Brewhouse Macadamia Nut Cookie Dough Net Case Wt.: 26 LB 4 oz.. Frozen Net Unit Wt. 3 oz. Approximate Count:140 Product Code: 13804 UPC: 0 00 49800 13804 9
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0401-2018·2017-11-29

    Ventura Foods Recalls SunGlow Margarine Due to Undeclared Soy Lecithin

    Ventura Foods is recalling SunGlow Unsalted European Style Butter Blend Margarine because it contains undeclared soy lecithin, a common allergen.

    Product
    SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Outer case: Net Wt 36 lb (16.32 kg). UPC 1 00 26700 13499 6. Ventura Foods, Brea, CA 92821
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0336-2018·2017-11-29

    Shoreline Fruit Recalls Dark Chocolate Covered Cherries Due to Undeclared Milk

    Shoreline Fruit is voluntarily recalling dark chocolate covered cherries because the supplier recalled dark chocolate containing undeclared milk.

    Product
    Shoreline Fruit Dark Choc Covered Montmorency Cherries packaged in 25-pound corrugated box
    Category
    Food
    Distribution
    47 states
  • HighFDA (Food)·F-0393-2018·2017-11-29

    Dilettante Chocolates Espresso Blend Recalled for Undeclared Almonds

    Seattle Gourmet Foods Inc. is recalling Dilettante Chocolates Espresso Blend sold at Costco because it may contain undeclared almonds.

    Product
    Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate., Costco item # 2335. The product is packaged in a clear plastic bag, net weight 5-pounds and has the UPC 37041 05211. The product label is read in parts: "***Dilettante Chocolates,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0107-2018·2017-11-29

    Medtronic MiniMed Quick-set Infusion Sets Recalled for Insulin Over-delivery Risk

    Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0134-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 893 Optetrak Offset Tibial Trays and Screws because of a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0163-2018·2017-11-29

    Medline Plastic Transfer Belts Recalled for Locking Mechanism Failure

    Medline Industries is recalling 1,428 plastic transfer belts because the locking mechanism may fail, allowing the strap to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2018·2017-11-29

    Medtronic MiniMed Silhouette Infusion Sets Recalled for Insulin Over-Delivery Risk

    Medtronic is recalling MiniMed Silhouette infusion sets because they may over-deliver insulin. The recall covers 1,898,570 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0114-2018·2017-11-29

    3M Recalls Bair Hugger Temperature Sensors Due to Programming Error

    3M is recalling Bair Hugger temperature sensors because a programming error may cause the device to display a temperature lower than the patient's actual body temperature.

    Product
    3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0109-2018·2017-11-29

    Medtronic MiniMed Sure-T Infusion Sets Recalled for Insulin Over-Delivery Risk

    Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.

    Product
    Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0136-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 683 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0123-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0121-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Saline Vials Recalled for Leaking Risk

    Halyard Health is recalling specific lots of 15ml saline vials used in the Turbo-Cleaning Closed Suction System because they may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0118-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Leaking Saline Vials

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0128-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 114 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0124-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Leaking Risk

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing the contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0315-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Blueberries for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Blueberries because they may contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Dark Chocolate Blueberries 8/7 oz., 8 pc. display, 25 lbs.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0374-2018·2017-11-29

    Givaudan Recalls Natural Mirepoix Flavor Due to Metal Fragments

    Givaudan Flavours Corp is recalling Natural Mirepoix Flavor because the firm was notified of metal fragments in the product.

    Product
    NATURAL MIREPOIX FLAVOR 181.4 kgs/drum Ingredients: Carrot Juice, Celery Juice Concentrate, Dextrose, Autolyzed Yeast Extract, Onion Juice Concentrate, Cabbage Juice Concentrate, Salt, Natural Flavoring Givaudan Flavors Corporation 9500 Sam Neace Drive Florence, KY 41042
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0133-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 801 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0385-2018·2017-11-29

    Woodstock Farms Dark Chocolate Cashews Recalled for Missing Milk Labeling

    United Natural Trading Inc. is recalling Market Basket Dark Chocolate Cashews because the label failed to list milk fat as an ingredient or include a 'contains milk' statement.

    Product
    Market Basket Dark Chocolate Cashews 8/12oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0120-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaks

    Halyard Health is recalling specific lots of Closed Suction Systems because the saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0162-2018·2017-11-29

    Medline Recalls Sensicare Green Surgical Gloves Due to Potential Sterility Breach

    Medline Industries is recalling 8,000 units of Sensicare Green Surgical Gloves because a possible open seal on the packaging could compromise sterility.

    Product
    Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0321-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Coffee Beans for Undeclared Milk

    GKI Foods is voluntarily recalling Dark Chocolate Coffee Beans because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Coffee Beans, 10 lbs., 15 lbs., 25 lbs., 12 pch Display, 8/8 oz., 12/10 oz., 12/8 oz.,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0112-2018·2017-11-29

    Medline Pediatric Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 190 units of pediatric elbow closed suction catheters because they were distributed before being sterilized.

    Product
    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0322-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Cranberry for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling multiple Dark Chocolate Cranberry products because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Cranberry, 20 lbs., 25 lbs., 8/8 oz., 8 pc. display, 18/12 oz., 15 lbs., 2 NDS,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0113-2018·2017-11-29

    Medline Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.

    Product
    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
    Category
    Medical Device
    Distribution
    7 states

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