The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
422
High
235
Moderate
212
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 45% are Severe.

Which agencies issued them

401–500 of 944

  • CriticalFDA (Food)·F-0147-2020·2019-11-20

    California New Foods Recalls Happy Trails Cookie Dough Due to Allergy Complaint

    California New Foods is recalling Happy Trails Cookie Dough after a consumer reported an allergic reaction. The product was distributed in California and Nevada.

    Product
    Country Baking Company; Pre-scooped & Ready to Bake: Happy Trails Cookie Dough All Natural, No Preservatives NET Wt. 24 ox. (1 lb. 8 oz.) Bakes 12 Jumbo cookies UPC Code 804879375845
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0145-2020·2019-11-20

    Frozen Cookie Doughballs Recalled Due to Allergic Reaction Complaint

    California New Foods is recalling Carolyn's Cookie Company Frozen Cookie Doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Snickerdoodle Net Wt. 22 oz. (623.7g) UPC Code 680569160317
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0319-2020·2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2020·2019-11-20

    Viatrexx-Articula Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Articula vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2020·2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to Possible NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 1,132,453 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0329-2020·2019-11-20

    Viatrexx-Ithurts Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Ithurts sterile multi-dose vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0142-2020·2019-11-20

    Frozen Cookie Doughballs Recalled Due to Allergic Reaction Complaint

    California New Foods is recalling 8,923 cases of Carolyn's Cookie Company Frozen Cookie Doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Double Chocolate with Sea Salt Net Wt. 22 oz. (623.7g) UPC Code 680569160263
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0140-2020·2019-11-20

    Carolyn's Cookie Company Recalls Frozen Oatmeal Raisin Cookie Doughballs

    California New Foods is recalling 8,923 cases of Carolyn's Cookie Company Frozen Oatmeal Raisin Cookie Doughballs due to a consumer complaint of an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Oatmeal Raisin Net Wt. 22 oz. (623.7g) UPC Code: 680569160294
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0334-2020·2019-11-20

    Viatrexx-Infla Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Infla vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0146-2020·2019-11-20

    Country Baking Company Recalls Chocolate Chip Cookie Dough Due to Allergy Complaint

    California New Foods is recalling Country Baking Company chocolate chip cookie dough after a consumer reported an allergic reaction.

    Product
    Country Baking Company; Pre-scooped & Ready to Bake: Chocolate Chip Cookie Dough All Natural, No Preservatives NET Wt. 24 ox. (1 lb. 8 oz.) Bakes 12 Jumbo cookies UPC Code 736211713483
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0335-2020·2019-11-20

    Viatrexx-Collagen Recalled for Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Collagen vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0228-2020·2019-11-20

    Pacific Coast Fruit Company Recalls Winter Citrus Slaw Kit for Listeria Risk

    Pacific Coast Fruit Company is recalling Winter Citrus Slaw Kits due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Winter Citrus Slaw Kit, item #71909, UPC 20728 71909. There are 2/7.2 lbs. bags of multiple ingredients per kit. Each kit contains multiple products and 4/12 oz. bags of Mann Packing Broccoli Cole Slaw: -Mann Packing Broccoli Cole Slaw (4/12 oz bags). -Bacon pieces -Red…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0342-2020·2019-11-20

    Viatrexx-Relief + Sterile Vials Recalled Due to Sterility Assurance Concerns

    Viatrexx Bio Incorporated is recalling Viatrexx-Relief + sterile vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2020·2019-11-20

    Heritage Medical 2000 Vascular Beds Recalled for Sudden Head Drop Hazard

    Heritage Medical Products is recalling 167 2000 Vascular beds due to a potential for the head of the bed to drop suddenly while a patient is lying on it.

    Product
    2000 Vascular with 30 Degree option
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0341-2020·2019-11-20

    Viatrexx-Immunexx Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling 18 vials of Viatrexx-Immunexx because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0347-2020·2019-11-20

    Viatrexx-Male+ Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Male+ sterile vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0326-2020·2019-11-20

    Viatrexx-Connectissue Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Connectissue vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2020·2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Possible NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0143-2020·2019-11-20

    Carolyn's Cookie Company Recalls Frozen Oatmeal Chocolate Chip Cookie Doughballs

    California New Foods is recalling 8,923 cases of Carolyn's Cookie Company Frozen Cookie Doughballs due to a consumer complaint of an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Oatmeal Chocolate Chip Net Wt. 22 oz. (623.7g) UPC Code 680569160300
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0348-2020·2019-11-20

    Viatrexx-ANS/CNS Recalled for Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-ANS/CNS vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0340-2020·2019-11-20

    Viatrexx-Arthros Recalled Due to Lack of Sterility Assurance

    Viatrexx-Arthros is being recalled because it was manufactured in a manner that cannot guarantee sterility. The product is distributed to physicians nationwide.

    Product
    Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2020·2019-11-20

    Apotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk

    Apotex Inc. is recalling Walgreens Maximum Strength Wal-Zan 150 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0307-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0345-2020·2019-11-20

    Viatrexx-Hair Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Hair sterile multi-dose vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0327-2020·2019-11-20

    Viatrexx-MuSkel-Neural Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-MuSkel-Neural vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg nationwide because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2020·2019-11-20

    Viatrexx-Neuro 3 Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Neuro 3 vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0141-2020·2019-11-20

    Carolyn's Cookie Company Recalls Frozen Cookie Doughballs Due to Allergy Complaint

    California New Foods is recalling Carolyn's Cookie Company frozen cookie doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Chocolate Chip Tasted Walnut Net Wt. 22 oz. (623.7g) UPC Code 680569160249
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0336-2020·2019-11-20

    Viatrexx-Prolo Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling 42 vials of Viatrexx-Prolo because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2020·2019-11-20

    Lannett Recalls Ranitidine Syrup Due to NDMA Impurity

    Lannett Company, Inc. is recalling 683,149 bottles of Ranitidine Syrup nationwide because NDMA impurity was detected.

    Product
    Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2020·2019-11-20

    Viatrexx-Ouch Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling 19 vials of Viatrexx-Ouch because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·19V835000·2019-11-20

    Isuzu and Chevrolet Trucks Recalled for Rear Wheel Lug Nut Defect

    Isuzu is recalling certain 2017-2020 Isuzu and Chevrolet trucks because rear outer wheel lug nuts may not have been properly tightened, increasing crash risk.

    Product
    ISUZU — ISUZU, CHEVROLET NPR HD, NPR XD, NQR, NRR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0139-2020·2019-11-20

    Frozen Cookie Doughballs Recalled Due to Allergic Reaction Complaint

    California New Foods is recalling Carolyn's Cookie Company Frozen Cookie Doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Chocolate Chip Net Wt. 22 oz. (623.7g) UPC Code 680569160232
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0339-2020·2019-11-20

    Viatrexx-GI Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-GI sterile multi-dose vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.

    Product
    Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2020·2019-11-20

    Viatrexx-Neuro Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Neuro vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2020·2019-11-20

    Viatrexx-Mesenchyme Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0370-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0343-2020·2019-11-20

    Viatrexx-Intra-Cell Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Intra-Cell vials because they were manufactured in a manner that cannot guarantee sterility.

    Product
    Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2020·2019-11-20

    Apotex Recalls Walgreens Wal-Zan 75 Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Walgreens Regular Strength Wal-Zan 75 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0331-2020·2019-11-20

    Viatrexx-Systemic Detox Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Systemic Detox vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0360-2020·2019-11-20

    Canon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting

    Canon Medical System, USA, INC. is recalling nine Infinix DP-i catheterization tables because liquid spills can trigger a short circuit, causing the table to tilt without operator control.

    Product
    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because the product was found to contain the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0330-2020·2019-11-20

    Viatrexx-Adipose Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Adipose vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2020·2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 162,344 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0337-2020·2019-11-20

    Viatrexx-Lymph 1 Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling Viatrexx-Lymph 1 vials because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2020·2019-11-20

    Viatrexx-Facial Vials Recalled Due to Lack of Sterility Assurance

    Viatrexx Bio Incorporated is recalling 13 vials of Viatrexx-Facial because the manufacturing process cannot guarantee sterility.

    Product
    Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2020·2019-11-20

    TriMed Locking Drill Guide Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 1,042 Locking Drill Guides because the epoxy coating on the instruments can pop off.

    Product
    TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2020·2019-11-20

    Tony's Canned Salmon Recalled for Potential Under-Processing

    Tony's Smokehouse and Cannery is recalling 6.5 oz. cans of Columbia Gorge Salmon because the product may have been under-processed and the lot code is missing from records.

    Product
    Tony's Columbia Gorge Salmon, Skinless and boneless salmon, packaged in a metal can, Net Wt. 6.5 oz./184g. The label reads in parts: "*** Columbia Gorge Salmon *** Ingredients: Salmon and Salt ***TONY'S SMOKEHOUSE AND CANNERY 1316 Washington Street Oregon City, OR 97045…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0369-2020·2019-11-20

    Carroll-Baccari Recalls Pedia Prep Skin Preparation Due to Contamination Risk

    Carroll-Baccari, Inc. is recalling Pedia Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 2,445 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0352-2020·2019-11-20

    Smiths Medical Recalls ProtectIV Plus Safety IV Catheters

    Smiths Medical is recalling certain lots of ProtectIV Plus Safety IV Catheters because the safety mechanism guard may be damaged.

    Product
    ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0368-2020·2019-11-20

    Carroll-Baccari Lemon Prep Skin Preparation Recalled for Potential Contamination

    Carroll-Baccari, Inc. is recalling Lemon Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 24,979 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0366-2020·2019-11-20

    TriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification

    TriMed Inc. is recalling 583 Olecranon Hook Plates because angled holes may have been modified from specifications without full qualification.

    Product
    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0404-2020·2019-11-20

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging

    Galil Medical is recalling 49 Visual-ICE Cryoablation Systems because the needles may clog or fail to freeze tissue adequately.

    Product
    Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control…
    Category
    Medical Device
    Distribution
    22 states
  • HighCPSC·20026·2019-11-20

    B&B Acquisition Recalls Wintergreen Essential Oils for Child-Resistant Packaging Failure

    B&B Acquisition is recalling Airome Wintergreen and Deep Soothe essential oils because the bottles lack child-resistant caps, posing a poisoning risk to young children.

    Product
    Airome Wintergreen Essential Oil and Deep Soothe Essential Oil 100 percent Pure & Natural Therapeutic Grade Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Food)·F-0149-2020·2019-11-20

    Food Lion Creamy Chocolate Frosting Recalled for Undeclared Milk Allergen

    Gilster-Mary Lee Corp. is recalling Food Lion Creamy Chocolate Frosting because cream cheese frosting was mislabeled as chocolate, failing to declare the major allergen milk.

    Product
    Food Lion Creamy Chocolate Frosting, Net Wt 16 OZ, Distributed by Food Lion, LLC, Salisbury, NC, foodlion.com, packaged in 12 cans per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0359-2020·2019-11-20

    TriMed Wrist Hook Impactors Recalled for Rust Risk

    TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.

    Product
    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0151-2020·2019-11-20

    Harris Teeter Ice Cream Recalled for Undeclared Soy Allergen

    Harris Teeter is recalling specific containers of Smooth & Creamy Take the Cake Ice Cream because the ingredient soy was not declared on the label.

    Product
    Harris Teeter SMOOTH & CREAMY TAKE THE CAKE ICE CREAM 1.5 QT (1.42L) container, Lower Fat, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 UPC 0 72036 98179 0
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·19V830000·2019-11-20

    Arcimoto Recalls 2019 FUV Motorcycles Due to Electrical Short Circuit Risk

    Arcimoto is recalling 25 units of the 2019 FUV motorcycle because a display board component may short circuit, potentially causing a sudden loss of power and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0152-2020·2019-11-20

    Harris Teeter Mint Chocolate Chip Ice Cream Recalled for Undeclared Soy

    Harris Teeter Supermarkets is recalling Mint Chocolate Chip Ice Cream because the ingredient soy was not declared in the product's ingredient statement or allergen declaration.

    Product
    Mint Chocolate Chip Ice Cream 1.5 QT (1.42L) container sold under the brand names of Harris Teeter ALL NATURAL, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC 0 72036 51151 5 & Lowes DISTRIBUTED BY: LOWES FOODS, LLC P.O. BOX 24908 WINSTON-SALEM, NC 27114-4908…
    Category
    Food
    Distribution
    3 states
  • HighCPSC·20025·2019-11-20

    Cutek Proclean Wood Restoration Recalled for FHSA Labeling Violations

    Deck Source is recalling Cutek Proclean Professional Wood Restoration because its label violates Federal Hazardous Substance Act requirements, posing a risk of poisoning.

    Product
    Cutek Proclean Professional Wood Restoration
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2020·2019-11-20

    Draeger Infinity M300 Telemetry Devices Recalled for Cybersecurity Vulnerabilities

    Draeger Medical Systems is recalling Infinity M300 telemetry monitoring devices due to cybersecurity vulnerabilities including DDoS, Spoofing, and Tampering.

    Product
    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2020·2019-11-20

    Orthofix Recalls Elbow Sterile Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Elbow Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0348-2020·2019-11-20

    Basic Reset Energy FX Recalled for Adulteration and Misbranding

    Basic Reset Inc. is recalling Energy FX products because FDA determined the marketing claims rendered the product a medical device that was adulterated and misbranded.

    Product
    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0137-2020·2019-11-20

    Riba Foods Recalls Arriba Bacon Salsa for Undeclared Milk

    Riba Foods Inc. is recalling Arriba! Bacon Salsa due to undeclared milk. The product was distributed in four states.

    Product
    Fire Roasted Medium Arriba! Bacon Salsa with Real Bacon NET WT 16 OZ. UPC Code: 033907 20513 1 packaged in a clear glass jar
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0153-2020·2019-11-20

    Harris Teeter Recalls Mint Chip Ice Cream for Undeclared Soy

    Harris Teeter is recalling Mint Chip Old Fashioned Ice Cream because soy was not declared in the ingredient statement or allergen declaration.

    Product
    THE FRESH MARKET Mint Chip OLD FASHIONED ICE CREAM 1.5 QT (1.42 L) container DISTRIBUTED BY: THE FRESH MARKET GREENSBORO, NC 27406 UPC 7 37094 01537 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0371-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0354-2020·2019-11-20

    Monarch Medical Technologies Recalls EndoTool SubQ Software Versions

    Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.

    Product
    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0396-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0350-2020·2019-11-20

    PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

    PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

    Product
    Universal Sexual Health Testing Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2020·2019-11-20

    Harris Teeter Ice Cream Recalled for Undeclared Soy Allergen

    Harris Teeter is recalling Premium Selections Chocolate Satisfaction Ice Cream because the ingredient soy was not declared on the label.

    Product
    Harris Teeter PREMIUM SELECTIONS CHOCOLATE SATISFACTION ICE CREAM 1.5 QT (1.42L) container PROUDLY DISTRIBUTED BY: HARRIS TEETER. LLC, MATTHEWS, NC 28105 UPC 0 72036 43030 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0365-2020·2019-11-20

    Cadence Science Pressure Control Glass Syringes Recalled for Breakage Risk

    Cadence Science is recalling 237 Pressure Control Glass Syringes because they may break during use, posing a potential injury risk to patients and healthcare workers.

    Product
    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of non-sterile drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0387-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect

    Orthofix Srl is recalling UE Xcaliber Metadiaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2020·2019-11-20

    Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0380-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0406-2020·2019-11-20

    Siemens SOMATOM CT Scanner Software Recall for System Crashes

    Siemens Medical Solutions is recalling syngo CT VB20 software for SOMATOM CT scanners due to scan aborts and system crashes.

    Product
    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2020·2019-11-20

    TriMed Countersink Instruments Recalled Due to Epoxy Coating Defect

    TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.

    Product
    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0377-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometric Design Defect

    Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0364-2020·2019-11-20

    Implant Direct Recalls Dental Implants Due to Packaging Error

    Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.

    Product
    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0398-2020·2019-11-20

    Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design

    Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0386-2020·2019-11-20

    Orthofix Radiolucent Wrist Fixator Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0349-2020·2019-11-20

    Synthes Trial Spacers Recalled for Modified Manufacturing Process

    Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.

    Product
    MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0532-2020·2019-11-20

    KVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles

    KVK-Tech is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution because black particles were found during inspection.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2020·2019-11-20

    Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect

    Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0374-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0401-2020·2019-11-20

    Orthofix Ankle Transfix Pin Sterile Kit Recalled for Design Defect

    Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0388-2020·2019-11-20

    Orthofix Recalls XCaliber Ankle Kits Due to Drill Bit Design Defect

    Orthofix is recalling XCaliber Ankle Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0361-2020·2019-11-20

    Exactech Recalls Fluted Pin Pouches Due to Potential Quantity Error

    Exactech is recalling 2.4mm x 2.5 Fluted Pin Pouches because they may contain one pin instead of four. The recall covers 9 units distributed in four states.

    Product
    2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0362-2020·2019-11-20

    Tec Com TECOTHERM NEO Thermo-Regulation System Recalled for Faulty Peltier Elements

    Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.

    Product
    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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