The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1751–1775 of 2769

  • LowFDA (Devices)·Z-1173-2016·2016-03-23

    Collagen Matrix Recalls ZCORE Porcine Xenograft Syringes for Malfunction

    Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe because the syringes were not working properly.

    Product
    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance pres
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1053-2016·2016-03-16

    GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuat
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0769-2016·2016-03-16

    Atorvastatin Calcium 40 mg Recalled for Impurity Failures

    Golden State Medical Supply Inc. is recalling Atorvastatin Calcium 40 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1052-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Manual Error

    GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained an incorrect torque value.

    Product
    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1048-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error

    GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.

    Product
    LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole b
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0768-2016·2016-03-16

    Golden State Medical Supply Recalls Atorvastatin Calcium 20 mg Tablets

    Golden State Medical Supply is recalling specific lots of Atorvastatin Calcium 20 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0770-2016·2016-03-16

    FDA Recalls Atorvastatin Calcium 80 mg Due to Impurity Failures

    Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 80 mg tablets because they failed impurity and degradation specifications.

    Product
    Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0711-2016·2016-03-09

    Frozen Specialties Recalls Hannaford Cheese Pizza for Kosher Labeling Error

    Frozen Specialties Inc is recalling Hannaford Cheese Crispy Thin Crust Pizza because the packaging displays a Kosher symbol, although the product is not Kosher.

    Product
    Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-0713-2016·2016-03-09

    Frozen Specialties Recalls Food Lion Crispy Thin Crust Pizza for Kosher Labeling

    Frozen Specialties Inc is recalling Food Lion microwaveable crispy thin crust pizza because the packaging displays a Kosher symbol that does not represent actual Kosher status.

    Product
    FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08821 5
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-0712-2016·2016-03-09

    Frozen Specialties Recalls Food Lion Pizza for Misleading Kosher Labeling

    Frozen Specialties Inc is recalling Food Lion Cheese Crispy Thin Crust Pizza because the packaging displays a Kosher symbol, but the products are not Kosher.

    Product
    FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08815 4
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-0734-2016·2016-03-09

    J. Strickland Recalls Subpotent Sulfur8 Anti-Dandruff Conditioner

    J. Strickland and Co is recalling Sulfur8 Medicated Light Formula anti-dandruff conditioner because it failed stability testing. The product is subpotent.

    Product
    sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0851-2016·2016-03-02

    BD FMC7 FITC Recalled for Incorrect Expiration Date Labeling

    Becton, Dickinson and Company is recalling 78 units of BD FMC7 FITC reagent because the vial labels display an incorrect expiration date.

    Product
    BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0728-2016·2016-03-02

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Injectable Suspension Due to Labeling Errors

    Isomeric Pharmacy Solution, LLC is recalling 114 vials of Triamcinolone Diacetate Injectable Suspension because some vials may have incorrect lot numbers or expiration dates.

    Product
    Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0840-2016·2016-03-02

    Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Issue

    Zimmer Biomet is recalling CR Flex and LPS Flex knee prostheses because the LDPE packaging bag adheres to the polished implant surface.

    Product
    CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0833-2016·2016-03-02

    Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion

    Zimmer Biomet is recalling NexGen Knee CR femoral components because the packaging bag adheres to the implant surface.

    Product
    NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0727-2016·2016-03-02

    Hospira Recalls Normosol-M Bags With Incorrect Expiration Date Labeling

    Hospira is recalling 10,778 bags of Normosol-M and 5% Dextrose Injection due to an incorrect expiration date printed on the primary container.

    Product
    Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0812-2016·2016-02-24

    C.R. Bard Recalls Toomey Syringes Due to Open Package Seal

    C.R. Bard is recalling 15,400 units of 70cc Toomey Syringes because a customer reported an open package seal.

    Product
    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0815-2016·2016-02-24

    Lab Vision Recalls CEA/CD66e Antibody Lots Due to Dilution Error

    Lab Vision Corporation is recalling specific lots of CEA/CD66e Ab-2 antibody because they were produced with an incorrect dilution factor.

    Product
    CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is re
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Drugs)·D-0720-2016·2016-02-24

    Dr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage

    Dr. Reddy's Laboratories is recalling Paricalcitol capsules due to reports of breakage and leakage. The recall covers 4,383 bottles distributed nationwide.

    Product
    PARICALCITOL — PARICALCITOL (PARICALCITOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·020-2016·2016-02-23

    Ajinomoto Recalls Pork Dumplings Misbranded as Beef

    Ajinomoto Windsor Inc. is recalling approximately 6,000 pounds of Shirakiku Gyoza Dumplings labeled as beef but containing undeclared pork.

    Product
    Ajinomoto Windsor Inc. — Recall Notification Report 020-2016 (Pork Products )
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0660-2016·2016-02-17

    Amerisource Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, due to failed impurities and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0784-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

    Zimmer Dental Inc. is recalling specific dental implants because safety information was missing from the instructions for use.

    Product
    IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or
    Category
    Medical Device
    Distribution
    Distributed nationwide