The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
243
High
266
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

601–700 of 833

  • SevereFDA (Drugs)·D-0566-2018·2018-02-07

    Unapproved herbal capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling HU HU SHENG WEI capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0270-2018·2018-02-07

    Medline Wound Closure Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 80 cases of Wound Closure Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0298-2018·2018-02-07

    Medline Recalls IV Start Kits With Subpotent Iodine Concentration

    Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0562-2018·2018-02-07

    Unapproved Sildenafil Tablets Recalled by FDA for Lack of Safety Data

    The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0268-2018·2018-02-07

    Medline I&D Tray Kits Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling I&D Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2018·2018-02-07

    Medline Recalls Povidone-Iodine Prep Pads Due to Subpotent Iodine Levels

    Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.

    Product
    Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2018·2018-02-07

    Medline Circumcision Tray Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Circumcision Tray Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0261-2018·2018-02-07

    Medline CNTRL Line Removal Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling CNTRL Line Removal Kit Scripps because the iodine content is below the label claim.

    Product
    Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2018·2018-02-07

    Medline Suture Removal Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim of 0.85%.

    Product
    Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0557-2018·2018-02-07

    FDA Recalls Unapproved Hard Ten Days Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Hard Ten Days capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0571-2018·2018-02-07

    FDA Recalls MACA Gold Tablets Containing Unapproved Sildenafil

    A&H Focal Inc. is recalling MACA gold tablets sold in New York and New Jersey because they contain sildenafil, an unapproved drug.

    Product
    MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0316-2018·2018-02-07

    Medline Abdominal Surgery Packs Recalled for Low Iodine Content

    Medline Industries is recalling Abdominal Surgery II Packs because the iodine content in the prep pads is below the label claim.

    Product
    Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2018·2018-02-07

    Medline Skin Stapler RMVR Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Skin Stapler RMVR trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2018·2018-02-07

    Medline Incision and Drainage Tray Recalled for Subpotent Iodine

    Medline is recalling Incision and Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2018·2018-02-07

    Medline Vitrectomy CDS Pack Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Vitrectomy CDS Packs because the iodine concentration is below the label claim of 0.85%.

    Product
    Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0300-2018·2018-02-07

    Medline Debridement Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Debridement Trays because the iodine concentration in the prep pads is below the label claim.

    Product
    Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Content

    Medline Industries is recalling Suture Removal Trays because the iodine content in the prep pads is below the labeled claim.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0419-2018·2018-02-07

    Stryker Mistral-Air Premium Blankets Recalled for Electrical Conductivity Risk

    Stryker is recalling Mistral-Air Premium Blankets because they may conduct electricity during high-energy defibrillation if applied upside down.

    Product
    MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0283-2018·2018-02-07

    Medline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content

    Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the label claim of 0.85%.

    Product
    Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0564-2018·2018-02-07

    STREE OVERLORD capsules recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling STREE OVERLORD capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0290-2018·2018-02-07

    Medline Skin Staple Remover Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Skin Staple Remover Kits because the iodine content is below the label claim of 0.85%.

    Product
    Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0570-2018·2018-02-07

    Unapproved Sildenafil Supplements Recalled by FDA for Lack of Safety Data

    A&H Focal Inc. is recalling LIEN CHAN FOR SEVEN DAYS capsules because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0258-2018·2018-02-07

    Medline Concordia Trunk Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Concordia Trunk Kits because the povidone-iodine prep pads contain less iodine than the label claims.

    Product
    Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2018·2018-02-07

    Medline Recalls Sterile Povidone-Iodine Prep Pads Due to Low Iodine Content

    Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.

    Product
    Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2018·2018-02-07

    Medline Catheter Insertion Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling sterile catheter insertion kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0567-2018·2018-02-07

    Unapproved Yanshijiaonang Capsules Containing Sildenafil Recalled by FDA

    A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0307-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0280-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 700 cases of Suture Removal Trays because the iodine concentration is below the label claim.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0552-2018·2018-02-07

    FDA Recalls Unapproved Black Ant Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0758-2018·2018-02-07

    Clover Valley Iced Oatmeal Cookies Recalled for Undeclared Allergens

    Dollar General is recalling Clover Valley Iced Oatmeal Cookies because they are actually Coconut Macaroon Cookies containing undeclared milk and tree nuts.

    Product
    Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CONTAINS: WHEAT, SOY. DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 UPC 0 86106 03201 5
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Food)·F-0644-2018·2018-02-07

    Coat & Bake Chicken Seasoning Recalled for Undeclared Milk Allergen

    Gilster-Mary Lee Corp. is recalling Coat & Bake Original Chicken seasoning because some packages contained pork seasoning with undeclared milk.

    Product
    Coat & Bake, Original Chicken, Seasoned Coating Mix For Chicken, Net Wt 5.5 OZ (156 g), Distributed by SuperValu Inc., Eden Prairie, MN.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0554-2018·2018-02-07

    FDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0303-2018·2018-02-07

    Medline Pacemaker Implant Pack Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Pacemaker Implant Packs because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2018·2018-02-07

    Medline Suture Removal Packs Recalled for Subpotent Iodine Content

    Medline Industries is recalling Suture Removal Packs because the iodine content is below the label claim of 0.85%.

    Product
    Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0565-2018·2018-02-07

    FDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil

    A&H Focal Inc. is recalling MAX MAN capsules sold in New York and New Jersey because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0256-2018·2018-02-07

    Medline RAD NECK ENT TRAY Povidone-Iodine Prep Pads Recalled for Subpotency

    Medline Industries is recalling RAD NECK ENT TRAY packs because the Povidone-Iodine prep pads contain subpotent iodine levels below the label claim.

    Product
    Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2018·2018-02-07

    Medline Staple Remover Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling sterile staple remover kits because the iodine concentration is below the labeled claim.

    Product
    Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2018·2018-02-07

    Medline Incision and Drainage Tray Recalled for Subpotent Iodine

    Medline Industries is recalling 73 cases of Incision & Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2018·2018-02-07

    Baxter Recalls Nexterone Injection Due to Polyethylene Particulate Matter

    Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection because polyethylene particulate matter was identified in the product packaging.

    Product
    NEXTERONE — NEXTERONE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0281-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration is below the label claim.

    Product
    Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Prep Pads in Hip Replacement Kits

    Medline Industries is recalling hip replacement kits containing Povidone-Iodine prep pads with iodine levels below the label claim of 0.85%.

    Product
    Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2018·2018-02-07

    Medline Catheter Care Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling lidded catheter care trays because the povidone-iodine prep pads contain less iodine than the label claims.

    Product
    Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2018·2018-02-07

    Germany Niubian tablets recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling Germany Niubian tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0308-2018·2018-02-07

    Medline Incision and Drainage Tray Recalled for Subpotent Iodine

    Medline is recalling sterile incision and drainage trays because the povidone-iodine prep pads contain less iodine than labeled.

    Product
    Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2018·2018-02-07

    Medline Recalls Suture Removal Kits With Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.

    Product
    Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0561-2018·2018-02-07

    Unapproved Ye Lang Shen capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling Ye Lang Shen capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0259-2018·2018-02-07

    Medline Concordia Nurse Bag Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 51 cases of Concordia Nurse Bag Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2018·2018-02-07

    Medline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content

    Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.

    Product
    Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2018·2018-02-07

    Medline Laceration Tray Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling 600 cases of Laceration Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0262-2018·2018-02-07

    Medline Trunk Kit Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2018·2018-02-07

    Medline Suture Removal Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.

    Product
    Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Prep Pads

    Medline Industries is recalling Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.

    Product
    Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0555-2018·2018-02-07

    Germany Black Gold tablets recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling Germany Black Gold tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0472-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0254-2018·2018-02-07

    Medline Vaginal Delivery CDS Pack Recalled for Subpotent Iodine

    Medline Industries is recalling Vaginal Delivery CDS Packs because the iodine content is below the label claim.

    Product
    Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the iodine concentration is below the labeled claim.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0559-2018·2018-02-07

    FDA Recalls Unapproved Gold Vigra Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Gold Vigra capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0697-2018·2018-02-07

    Ottogi Rice Cake Soup Recalled for Undeclared Milk Allergen

    Ottogi America Inc. is recalling Rice Cake Soup because it contains undeclared milk in the form of sodium caseinate.

    Product
    Ottogi Rice Cake Soup, 6.4oz. UPC 6 45175 89093 52; Item Number 29409101; Ingredients: 1. Rice Cake: Rice Water, Salt, Spirits; 2. Liquid Soup: Beef Bone Extract, Prim/starch syrup, coconut oil, sodium Caseinate, Water, Salt, Maltodextrin, Garlic, Chicken Extract Powder.…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0272-2018·2018-02-07

    Medline DC Line Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling DC Line Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Prep Pads

    Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.

    Product
    Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0560-2018·2018-02-07

    FDA Recalls Unapproved Clalis Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Clalis capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0317-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2018·2018-02-07

    Medline Central Line Dressing Change Tray Kit Recalled for Subpotent Iodine

    Medline is recalling Central Line Dressing Change Tray Kits because the iodine concentration in the prep pads is below the label claim.

    Product
    Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2018·2018-02-07

    Medline General Purpose Kit Recalled for Subpotent Povidone-Iodine

    Medline Industries is recalling General Purpose Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2018·2018-02-07

    Medline Recalls Pediatric IV Kits With Subpotent Iodine Concentration

    Medline Industries is recalling Pediatric IV Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2018·2018-02-07

    Medline Recalls IV Start Kits With Subpotent Povidone-Iodine

    Medline Industries is recalling IV Start Kits because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Povidone-Iodine

    Medline Industries is recalling suture removal trays because the povidone-iodine prep pads contain less iodine than labeled.

    Product
    Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0568-2018·2018-02-07

    FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0273-2018·2018-02-07

    Medline Dressing Change Tray Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V095000·2018-02-07

    Keystone Recalls 2018 Crossroads Sunset Trailers Due to Incorrect Tires

    Keystone RV is recalling 2018 Crossroads Sunset trailers because they may have tires with an incorrect load rating, which could lead to tire failure and a crash.

    Product
    CROSSROADS — CROSSROADS SUNSET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0700-2018·2018-02-07

    Claudio Specialty Foods Recalls Anchovy Sauce Due to High Histamine Levels

    Claudio Specialty Foods is recalling specific lots of Sapori di Mare Colatura di Alici di Cetura anchovy sauce because the product contains high levels of histamine.

    Product
    Sapori di Mare Colatura di Alici di Cetura; Anchovy Sauce; 100 ml, Lot #'s 03/2017 or 09/2017.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0501-2018·2018-02-07

    Beaver Safety Sideport Knife Recalled Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling specific batches of Beaver Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0691-2018·2018-02-07

    Mary B's Tea Biscuits Recalled for Potential Listeria Contamination

    Hom'ade Foods is recalling Mary B's Tea Biscuits due to potential Listeria monocytogenes contamination. Consumers should check their packages for specific dates and codes.

    Product
    Mary B's Tea Biscuits, 24 Biscuits, Bite-Sized, NET WT. 24 oz (1LB 8 OZ) 680g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0447-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0752-2018·2018-02-07

    Wegmans Garlic Parmesan Tilapia Recalled for Undeclared Soy Lecithin

    Wegmans is recalling specific packages of Ready To Cook Garlic Parmesan Tilapia because they may contain undeclared soy lecithin, a common allergen.

    Product
    Wegmans Ready To Cook Garlic Parmesan Tilapia, Single, 5 oz UPC: 2-16150-00000 and Wegmans Ready To Cook Garlic Parmesan Tilapia, Twin Pack, 15 oz UPC: 2-16154-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0451-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2018·2018-02-07

    Beaver Xstar Safety Slit Knives Recalled Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling 659,370 units of bvi Beaver Xstar Safety Slit Knives because the protective shield was retracted, exposing the blade.

    Product
    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0688-2018·2018-02-07

    Hom'ade Foods Recalls Mary B's Jumbo Biscuits for Listeria Risk

    Hom'ade Foods is recalling Mary B's Jumbo Biscuits because they may be contaminated with Listeria monocytogenes. Consumers should check their pantries for affected products.

    Product
    Mary B's Jumbo, 10 Biscuits, Extra Large, NET WT. 35 oz (2LB 3OZ) 992g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0453-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues

    Horiba Medical is recalling ABX PENTRA reagent cups that may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2018·2018-02-07

    Ormco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers

    Ormco/Sybronendo is recalling 25,765 Elements Obturation Units and Buchanan Heat Pluggers because the pluggers may overheat during use.

    Product
    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2018·2018-02-07

    Baxter Recalls 500mL IntraVia Containers Due to Potential Sterility Leak

    Baxter Healthcare is recalling 29,088 units of 500mL IntraVia containers in the US and Canada because a leak may allow microbial contamination of the sterile fluid path.

    Product
    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0435-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the device from being properly assembled.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2018·2018-02-07

    Beaver-Visitec Recalls Safety Knives Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling specific EdgeAhead Safety Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide

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