The Recall Desk

Archive

December 2017 recalls

389 recalls were announced in December 2017.

What the numbers show

Critical
38
Severe
74
High
172
Moderate
94
Low
11

Of the 389 recalls this month scored against our rubric, 10% are Critical, 19% are Severe.

1–100 of 389

  • HighNHTSA·17V847000·2017-12-29

    ShowHauler Recalls 2003-2018 Motorhomes Due to Fire Extinguisher Defect

    ShowHauler is recalling 2003-2018 Garage Coach, Toter Coach, and Motorhome vehicles because their fire extinguishers may clog or detach, posing injury risks during a fire.

    Product
    SHOWHAULER — SHOWHAULER GARAGE COACH, TOTER COACH, MOTORHOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V846000·2017-12-28

    Forest River Recalls 2017-2018 Georgetown RVs for Brake Defect

    Forest River is recalling 2017-2018 Georgetown recreational vehicles because missing plugs in the brake system may cause fluid leaks or air ingestion, increasing stopping distance.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18073·2017-12-28

    Western Gas Recalls Propane Due to Fire and Burn Hazards

    Western Gas is recalling under-odorized propane gas due to fire, explosion, and burn hazards. Consumers should contact their supplier for a free inspection.

    Product
    Propane (LP) Gas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0529-2018·2017-12-27

    Old Dutch Potato Chips Recalled for Potential Salmonella Contamination

    Old Dutch Foods is recalling Cheddar & Sour Cream flavored potato chips because a seasoning ingredient may contain milk contaminated with Salmonella.

    Product
    Cheddar & Sour Cream flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 2 oz, UPC 74690-024066; 8 oz., UPC 74690-230290; and 15.5 oz., UPC 74690-205694. 2. Old Dutch Rip-L Family Pack, 9.5oz, UPC 74690-201160 3. Roundy's, 2 oz, U
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Drugs)·D-0122-2018·2017-12-27

    LaBri's Body Health XPLODE Recalled for Unapproved Sibutramine

    EZWeightLossTX LLC is recalling LaBri's Body Health XPLODE capsules because they contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0121-2018·2017-12-27

    FDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination

    EZWeightLossTX LLC is recalling LaBri's Body Health Atomic 60 Capsules because the product was found to contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0115-2018·2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling Nitroglycerin injection syringes found to be subpotent, meaning they contain less active ingredient than labeled.

    Product
    NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0126-2018·2017-12-27

    FDA Recalls Natural Herbal Coffee AMPT for Undeclared Sildenafil and Tadalafil

    The FDA is recalling Natural Herbal Coffee AMPT because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.

    Product
    NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0531-2018·2017-12-27

    Old Dutch Potato Chips Recalled Due to Potential Salmonella Contamination

    Old Dutch Foods is recalling French Onion flavored potato chips because a seasoning ingredient may contain milk contaminated with Salmonella.

    Product
    Old Dutch Ripples French Onion flavored Potato Chips, 2 oz., UPC 74690-023670, and 8 oz. UPC 74690-230160.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0530-2018·2017-12-27

    Old Dutch Foods Recalls Jalapeno Popper Potato Chips Due to Salmonella Risk

    Old Dutch Foods is recalling specific lots of Jalapeno Popper flavored potato chips because a seasoning ingredient contains milk that may be contaminated with Salmonella.

    Product
    Jalapeno Popper flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 3 oz, UPC 74690-028590; and 8 oz., UPC 74690-231556. 2. Roundy's, 10.5 oz, UPC 11150-224499.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Drugs)·D-0123-2018·2017-12-27

    Pfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter

    Pfizer Inc. is recalling 102,500 vials of Vancomycin Hydrochloride for Injection due to the presence of glass particulate matter.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0532-2018·2017-12-27

    Lund's & Byerly's Chipotle Ranch Potato Chips Recalled for Salmonella Risk

    Old Dutch Foods is recalling Lund's & Byerly's Chipotle Ranch Potato Chips because a seasoning ingredient contains milk that may be contaminated with Salmonella.

    Product
    Lund's & Byerly's Chipotle Ranch flavored Potato Chips, 8 oz., UPC 72431-009792.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0113-2018·2017-12-27

    Advanced Pharma Recalls Subpotent NitroGlycerin Injection Syringes Nationwide

    Advanced Pharma Inc. is recalling 550 syringes of NitroGlycerin injection found to be subpotent. The product was distributed nationwide to hospitals and medical facilities.

    Product
    NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0128-2018·2017-12-27

    Perrigo Recalls Zephrex-D Nasal Decongestant Due to Microbial Contamination

    L. Perrigo Company is recalling Zephrex-D nasal decongestant softgels due to microbial contamination. Consumers should stop using the product and return it to the pharmacy.

    Product
    Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0114-2018·2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling 320 syringes of Nitroglycerin injection that were found to be subpotent, meaning they contain less active ingredient than labeled.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V844000·2017-12-27

    Thor Motor Coach Recalls 2018 Freedom Traveler Motorhomes for Fire Risk

    Thor Motor Coach is recalling 2018 Freedom Traveler motorhomes because a missing heat shield between the propane tank and generator exhaust pipe increases the risk of fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM TRAVELER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0120-2018·2017-12-27

    Amneal Recalls Lorazepam Oral Concentrate Due to Defective Dropper Markings

    Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate because dropper measurement markings may be reversed, shifted, or missing, which could lead to dosing errors.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·18069·2017-12-27

    Rocky Mountain Bicycles Recall Mountain Bikes Due to Crash Hazard

    Rocky Mountain Bicycles is recalling 2018 Altitude, Instinct, and Pipeline models because improperly secured brake cable housing can cause brake failure and crashes.

    Product
    Mountain bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2018·2017-12-27

    Qiagen QIAamp DSP Virus Kit Recalled for Decreased Performance

    Qiagen is recalling specific lots of the QIAamp DSP Virus Kit because they may result in decreased performance in analytic workflows.

    Product
    QIAamp DSP Virus Kit Cat. No. 60704
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0508-2018·2017-12-27

    Kroger Dark Chocolate Covered Almonds Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Almonds because the product may contain an undeclared milk allergen.

    Product
    All Natural Dark Chocolate Covered Almonds INGREDIENTS: Natural Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), Almonds And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0512-2018·2017-12-27

    Kroger Dark Chocolate Covered Pretzel Balls Recalled for Undeclared Milk

    The Kroger Co is recalling All Natural Dark Chocolate Covered Pretzel Balls because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Pretzel Balls INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (EMULSIFIER), SALT, VANILLA), PRETZEL BALLS (ENRICHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0511-2018·2017-12-27

    Kroger Recalls Dark Chocolate Covered Ginger for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Ginger because it may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Ginger INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (EMULSIFIER), SALT, VANILLA), GINGER (DICED/SLICED GINGER, SUGAR) AND CONFECTIONERS GLAZE. DISTRIBUTED BY THE KROGER
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0282-2018·2017-12-27

    Zimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect

    Zimmer Dental Inc. is recalling 891 Tapered Screw-Vent Implant System surgical kits because a manufacturing defect in the driver's hex feature may prevent proper engagement with dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0280-2018·2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2018·2017-12-27

    Terumo Overpressure Safety Valve Recall Due to No Flow Reports

    Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.

    Product
    Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0256-2018·2017-12-27

    Terumo Overpressure Safety Valve Recalled Due to No Flow Reports

    Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.

    Product
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0513-2018·2017-12-27

    Kroger Dark Chocolate Covered Raisins Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Raisins because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Raisins INGREDIENTS: Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), raisins And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0510-2018·2017-12-27

    Kroger Recalls Dark Chocolate Covered Cranberries Due to Undeclared Milk Allergen

    The Kroger Co is recalling 4,127 pounds of All Natural Dark Chocolate Covered Cranberries because the product may contain an undeclared milk allergen.

    Product
    All Natural Dark Chocolate Covered Cranberries INGREDIENTS: DARK CHOC (SUGAR, CHOC LIQUOR, COCOA BUTTER, SALT, VANILLA) CRANBERRIES, CONFECTIONERS GLAZE. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0509-2018·2017-12-27

    Kroger Dark Chocolate Covered Coffee Beans Recalled for Undeclared Milk Allergen

    The Kroger Co is recalling All Natural Dark Chocolate Covered Coffee Beans because they may contain an undeclared milk allergen. The product was distributed in Michigan.

    Product
    All Natural Dark Chocolate Covered Coffee Beans INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (AN EMULSIFIER), VANILLA, SALT, AND ARTIFICIAL FLAVORING ADDED), DRY ROASTED COFFEE BEANS AND CONFECTIONERS GLA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0266-2018·2017-12-27

    Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk

    Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.

    Product
    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0554-2018·2017-12-27

    HERB-OX Beef Bouillon Recalled for Undeclared Milk Allergen

    Creative Contract Packaging is recalling HERB-OX Beef Flavor Granulated Bouillon due to potential undeclared milk allergen.

    Product
    HERB-OX Beef Flavor Granulated Bouillon, 4 ounce jars
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0265-2018·2017-12-27

    BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2018·2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0503-2018·2017-12-27

    Sensations Cinnamon Roll Dough Recalled for Undeclared Pecans

    AMS LLC dba Gagne Foods is recalling 37 cases of Sensations cinnamon roll UNCOOKED DOUGH 450g in Canada due to undeclared pecans.

    Product
    Sensations cinnamon roll UNCOOKED DOUGH 450g, UPC: 236821197
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0116-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL syringes because stability data does not support the expiry dates. The recall affects 4,800 syringes distributed nationwide to hospitals.

    Product
    NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0263-2018·2017-12-27

    Invivo Recalls Xper Flex Cardio Physiomonitoring Systems Due to Communication Issues

    Invivo Corporation is recalling 4,535 Xper Flex Cardio Physiomonitoring systems because of intermittent communication between the host system and the device.

    Product
    Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-0125-2018·2017-12-27

    Teva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling

    Teva Pharmaceuticals is recalling Amethyst oral contraceptive tablets because the packaging incorrectly states that Week 4 tablets are inactive, when all tablets are active.

    Product
    Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0129-2018·2017-12-27

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes because the printed beyond-use dates exceed current stability data.

    Product
    Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0118-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2018·2017-12-27

    Zimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 166 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0516-2018·2017-12-27

    Raley's Recalls Meyer Lemon Cookies Due to Plastic Contamination

    Raley's is recalling All Butter Meyer Lemon Cookies because plastic material was found in unbaked cookies at a retail store. The recall affects 57 cases of cookies distributed in California and Nevada.

    Product
    Raley's All Butter Meyer Lemon Cookie; Case of Raw Dough (168 cookies) 28.87 lbs - UPC 10659728; 1 cookie (85 g); 6 count package UPC 4656760890 sold in retail stores Individual cookies in Bakery Case - identifier 106 Ingredients: ENRICHED BLEACHED WHEAT FLOUR (WHEAT FLOUR
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0127-2018·2017-12-27

    Claris Recalls Ciprofloxacin Injection Due to Superpotency

    Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection because the product is superpotent. The recall is voluntary and nationwide.

    Product
    Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin injection syringes because stability data does not support the product's expiry date.

    Product
    NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0117-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL syringes because stability data does not support the product's expiry date.

    Product
    NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2018·2017-12-27

    Zimmer Biomet Recalls ExploR Radial Head Replacement System Due to Missing Screw

    Zimmer Biomet is recalling the ExploR Radial Head Replacement System because a complaint alleged the modular lock screw was missing from the package.

    Product
    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0278-2018·2017-12-27

    Philips HeartStart MRx Defibrillators Recalled for EtCO2 Module Contamination

    Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.

    Product
    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0272-2018·2017-12-27

    Stryker Recalls Mislabeled VenaFlow Calf Compression Garments

    Stryker is recalling 280 VenaFlow Calf Garments mislabeled as Pos-Lock Connectors in Texas due to labeling errors.

    Product
    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0267-2018·2017-12-27

    C.R. Bard Recalls I-125 QuickLink Cartridges Due to Incorrect Quantity

    C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.

    Product
    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to tr
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0111-2018·2017-12-27

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is voluntarily recalling 9,919 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets distributed nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2018·2017-12-27

    Philips Medical Imaging Systems Recalled for Measurement Export Error

    Philips is recalling 157 medical imaging systems because a software option prevents correct export of measurement data to external destinations.

    Product
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0277-2018·2017-12-27

    Stryker Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific stroke intervention kits because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0502-2018·2017-12-27

    John Zidian Recalls Gia Russa Spaghetti Sauce Due to Mold

    John Zidian Co is recalling Gia Russa Spaghetti Dinner Sauce due to mold contamination and popped lids. The product was distributed in New York, Ohio, and Pennsylvania.

    Product
    Gia Russa Spaghetti Dinner Sauce TRADITIONAL NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified Food Starch, Salt, Garlic, Onions, Citric Acid, Oregano, Basil Distributed By: Gia Brands Inc., Boardman, OH 44512 UPC 0 26825 00832 8
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0112-2018·2017-12-27

    B. Braun Recalls Acetic Acid Irrigation Due to Particulate Matter

    B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP due to the presence of polyethylene particulate matter.

    Product
    ACETIC ACID — ACETIC ACID (ACETIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0501-2018·2017-12-27

    John Zidian Recalls Gia Russa Spaghetti Sauce Due to Mold

    John Zidian Co is recalling Gia Russa Spaghetti Dinner Sauce Mushrooms due to mold contamination and popped lids. The product was distributed in New York, Ohio, and Pennsylvania.

    Product
    Gia Russa Spaghetti Dinner Sauce Mushrooms NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified Food Starch, Salt, Mushrooms, Garlic, Onions, Citric Acid, Oregano, Basil Distributed By: Gia Brands Inc., Boardman, OH 44512 UPC 0 26825 00830
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0283-2018·2017-12-27

    Implant Direct Recalls Spectra Guided Surgery Handle Kits for Dimensional Defects

    Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.

    Product
    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2018·2017-12-27

    C.R. Bard Recalls Medivance ArcticGel Small Pad Kits Due to Peeling

    C.R. Bard is recalling 24 Medivance ArcticGel Small Pad Kits because the hydrogel is peeling from the pads. The affected units were distributed to 10 US states.

    Product
    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling pati
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0275-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0268-2018·2017-12-27

    Philips SureSigns Vital Signs Monitors Recalled for Labeling Error

    Philips is recalling SureSigns VSi and VS2+ vital signs monitors because some units have a placeholder date of manufacture instead of the specific date.

    Product
    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0124-2018·2017-12-27

    Renaissance Lakewood Recalls Superpotent Fluconazole Injection Bags Nationwide

    Renaissance Lakewood, LLC is voluntarily recalling 24,569 bags of Fluconazole Injection, USP, 2 mg/mL, due to superpotency. The FDA classified this as Class III.

    Product
    Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0110-2018·2017-12-27

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is voluntarily recalling 10,064 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0500-2018·2017-12-27

    Hain Celestial Recalls BluePrint Organic Beet Blast Drinks Due to Labeling Error

    The Hain Celestial Group is recalling 1,949 cases of BluePrint Organic Beet Blast Vegetable & Fruit Drink because the label on the back of the bottle may be for the incorrect product.

    Product
    BluePrint ORGANIC Beet Blast Vegetable & Fruit Drink 16 fl.oz.(473mL) USDA Organic. Keep Refrigerated.
    Category
    Food
    Distribution
    13 states
  • LowFDA (Food)·F-0522-2018·2017-12-27

    New Century Snacks Recalls Mixed Nuts Due to Incorrect Back Panel Labeling

    New Century Snacks LLC is recalling Happy Belly Deluxe Mixed Nuts because the back panel ingredients and nutrition facts were incorrect. The principal display label correctly lists the main allergens.

    Product
    Happy Belly Deluxe Mixed Nuts - roasted and salted with sea salt. Cashews, Almonds, Brazil nuts, pecans & Hazelnuts 16 oz. (454 g); Allergen information: contains Milk, Almonds, Wheat, Peanuts. UPC 48719 09577 Cranberry & Nuts Trail mix has dried cranberries, cashew & a
    Category
    Food
    Distribution
    10 states
  • LowFDA (Food)·F-0523-2018·2017-12-27

    New Century Snacks Recalls Happy Belly Cranberry and Nuts Trail Mix

    New Century Snacks LLC is recalling Happy Belly Cranberry & Nuts Trail Mix because the back panel ingredients and nutrition facts were incorrect.

    Product
    Happy Belly Cranberry & Nuts Trail Mix - dried cranberries, cashews and almonds. 16 oz. (454 g); Allergens: almonds, Cashews UPC 48719 09587 Cranberry & Nuts Trail Mix - Dried cranberries (cranberries, sugar, sunflower oil), cashews, almonds, vegetable oil (may contain one
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·131-2017·2017-12-26

    Swift Beef Company Recalls Beef Stew Products Due to Foreign Matter

    Swift Beef Company is recalling approximately 4,702 pounds of beef stew products sold in Texas due to possible contamination with plastic and metal.

    Product
    Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V843000·2017-12-26

    Newmar Recalls 2017 Motorhomes Due to Brake Fluid Leak Risk

    Newmar is recalling 2017 Bay Star, Bay Star Sport, and Canyon Star motorhomes because missing plugs in the brake system may cause fluid leaks or air ingestion, increasing stopping distance.

    Product
    NEWMAR — NEWMAR BAY STAR SPORT, BAY STAR, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V841000·2017-12-22

    Tiffin Motorhomes Recall Fire Extinguishers in Multiple Models

    Tiffin is recalling 2009-2018 motorhomes because Kidde fire extinguishers may clog or detach, potentially failing to work during a fire.

    Product
    TIFFIN — TIFFIN ALLEGRO, BREEZE, BUS, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18071·2017-12-22

    Vilo Home Recalls Marseille Dining Benches Due to Fall Hazard

    Vilo Home is recalling Marseille dining benches because the foam seat cushion and base can crack, causing the bench to collapse and posing a fall hazard.

    Product
    Marseille dining benches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V840000·2017-12-22

    PACCAR Recalls 2018 Kenworth and Peterbilt Trucks for Transmission Defect

    PACCAR is recalling 2018 Kenworth and Peterbilt trucks because the transmission control module may allow the engine to start without the shifter in neutral, risking unintended movement.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, T880, 567, 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·130-2017·2017-12-21

    PFP Enterprises Recalls Ground Beef for Undeclared Soy Allergen

    PFP Enterprises LLC is recalling approximately 7,570 pounds of ground beef products due to misbranding and an undeclared soy allergen. The raw, frozen products were shipped to distributors and institutions in Texas.

    Product
    PFP Enterprises LLC Recalls Ground Beef Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·18708·2017-12-21

    Polaris Recalls RZR XP 4 Turbo Vehicles Due to Fire Hazard

    Polaris is recalling about 560 RZR XP 4 Turbo vehicles because an improperly secured fuel line can leak and cause a fire.

    Product
    Polaris RZR XP 4 Turbo ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V834000·2017-12-21

    Maserati Recalls 2018 Quattroporte and Ghibli for Fuel Leak Risk

    Maserati is recalling 2018 Quattroporte and Ghibli vehicles because a fuel delivery pipe may leak, increasing the risk of a fire.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V842000·2017-12-21

    Hyundai Translead Recalls 2017 Trailers Due to Brake Caliper Bolt Defect

    Hyundai Translead is recalling 2017 Composite and HyCube trailers because improperly torqued brake caliper bolts may allow the caliper to detach, increasing crash risk.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD COMPOSITE, HYCUBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18070·2017-12-21

    Wohali Outdoors Recalls Children's Pajama Sets for Flammability Violations

    Wohali Outdoors is recalling about 26,800 children's three-piece pajama sets sold at Bass Pro Shops because they fail federal flammability standards, posing a risk of burn injuries.

    Product
    Children's three-piece pajama sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18709·2017-12-21

    John Deere Recalls Crossover Gator Utility Vehicles Due to Steering Loss

    John Deere is recalling about 68,300 Crossover Gator utility vehicles because the steering shaft can separate, causing a loss of steering control and posing a crash hazard.

    Product
    John Deere Crossover Gator™ utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18074·2017-12-21

    Brompton Recalls Folding Bicycles Due to Bottom Bracket Fall Hazard

    Brompton is recalling about 8,400 folding bicycles because the bottom bracket can break during use, posing a fall hazard. No injuries have been reported.

    Product
    Folding Brompton bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18072·2017-12-21

    Honda Recalls Portable Generators Due to Fire and Burn Hazards

    American Honda is recalling about 34,000 portable generators because a leaking carburetor poses fire and burn risks. No injuries have been reported.

    Product
    Honda portable generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V824000·2017-12-21

    Chrysler Recalls Vehicles with Defective Kidde Fire Extinguishers

    Chrysler is recalling various Dodge, Jeep, and RAM vehicles equipped with specific Kidde fire extinguishers that may clog or detach, posing injury risks.

    Product
    DODGE — DODGE, RAM, JEEP DURANGO, CHALLENGER, RAM 1500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0491-2018·2017-12-20

    Wang Globalnet Fish Cake Recalled for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Cake in Polybag due to undeclared egg and wheat allergens. The product was distributed across 11 states.

    Product
    Fish Cake in Polybag 10/2.2lbs, Item no. 12842 UPC Code 087703128422
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0492-2018·2017-12-20

    Wang Globalnet Fish Cake Recalled for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Cake in Polybag 10/930g because it contains undeclared egg and wheat allergens.

    Product
    Fish Cake in Polybag 10/930g, Item no. 15731 UPC Code 087703157316
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·17V833000·2017-12-20

    Walker Recalls 2018 Tank Trailers Due to Brake Caliper Bolt Issues

    Walker is recalling 2018 Tank Trailers because improperly torqued brake caliper bolts may allow the caliper to detach, causing a loss of braking ability.

    Product
    WALKER — WALKER TANK TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0490-2018·2017-12-20

    Wang Globalnet Recalls Fish Tofu for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Tofu in Polybag 40/240g because the product contains undeclared egg and wheat allergens.

    Product
    Fish Tofu in Polybag 40/240g, Item no. 17185, UPC Code 087703171855
    Category
    Food
    Distribution
    11 states

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