The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

20201–20225 of 21633

  • ModerateFDA (Devices)·Z-1806-2013·2013-07-31

    Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching

    Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.

    Product
    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-814-2013·2013-07-31

    LA MER Sunscreen Recalled for Potentially Reduced Sun Protection

    Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient avobenzone may be subpotent, potentially reducing the product's effectiveness.

    Product
    LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-800-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-797-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1730-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System for Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System due to software algorithm inaccuracies. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1745-2013·2013-07-24

    Synthes Recalls Multi Vector Distractor Pin Holding Clamps Due to Binding

    Synthes USA is voluntarily removing Multi Vector Distractor Pin Holding Clamps because the clamp and nut construct may fail to engage threads and bind.

    Product
    Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-802-2013·2013-07-24

    Quetiapine Fumarate Tablets Recalled for Failed Dissolution Test

    American Health Packaging is recalling Quetiapine Fumarate 25mg tablets because they failed a dissolution test during stability studies.

    Product
    QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2013·2013-07-24

    Paa Laboratories Recalls Fetal Bovine Serum Due to Mislabeling

    Paa Laboratories is recalling approximately 280,000 liters of Fetal Bovine Serum because some products labeled as pure may contain added adult Bovine Serum Albumin.

    Product
    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2013·2013-07-24

    Karl Storz Balloon Catheter Recalled for Potential Sterility Compromise

    Karl Storz Endoscopy America is recalling 27023WU Balloon Catheters because packaging defects may compromise sterility. The recall affects 40 units distributed to five US states.

    Product
    27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1744-2013·2013-07-24

    Zeiss Microscope Polarizer D Component Recalled for Misaligned Plate

    Carl Zeiss Microscopy is recalling Polarizer D components for upright Zeiss microscopes due to a misaligned full-wave plate.

    Product
    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1752-2013·2013-07-24

    Baxter Recalls ExactaMix Compounders Due to Battery Clock Reset

    Baxter Healthcare is recalling ExactaMix 1200 and 2400 compounders because a battery failure causes the internal clock to reset to midnight on December 31, 2010.

    Product
    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1726-2013·2013-07-24

    Synthes CMF Distraction System Recalled for Misalignment

    Synthes USA HQ, Inc. is voluntarily recalling 10 units of the Synthes CMF Distraction System due to a misalignment issue that prevents the attachment of specific foot plates.

    Product
    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

    Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Surgeon Side Carts for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-686-2013·2013-07-17

    Hospira Recalls Gentamicin Sulfate Injection Due to Visible Particulate Matter

    Hospira Inc. is recalling 168,300 vials of Gentamicin Sulfate Injection USP 80 mg/2 mL because visible particles were found floating in the primary container.

    Product
    GENTAMICIN SULFATE — GENTAMICIN SULFATE (GENTAMICIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2013·2013-07-17

    AngioDynamics RITA Main Cable Recalled for Incorrect Instructions for Use

    AngioDynamics is recalling 13 RITA Main Cables because they contain incorrect Instructions for Use. The cables are used with RITA RF Generators and electrosurgical devices.

    Product
    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1651-2013·2013-07-17

    Christian Cheese Blackberry Wine Cheese Recalled for Undeclared Sulfites

    Christian Cheese, LLC is recalling Blackberry Wine Cheese made in Kingfisher, Oklahoma, due to undeclared sulfites. The product was distributed in Colorado and Oklahoma.

    Product
    Christian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, Blackberry Wine. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1725-2013·2013-07-17

    SagaTech Finger Sensor for Remmers Recorder Recalled for Premature Jacket Recession

    SagaTech Electronics is recalling 152 Finger Sensors for Remmers Recorders because the outer jacket is receding prematurely from the black sensor.

    Product
    Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2013·2013-07-17

    Zimmer Recalls Mislabelled Shoulder Trial Stem Devices

    Zimmer, Inc. is removing one lot of Bigliani/Flatow Humeral Provisional Stems because 14mm devices were incorrectly etched and packaged as 12mm.

    Product
    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1682-2013·2013-07-17

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-690-2013·2013-07-17

    Teva Recalls Camila Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Camila (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-689-2013·2013-07-17

    Teva Recalls Errin Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Errin (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-684-2013·2013-07-17

    Teva Recalls Balziva Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Balziva (norethindrone and ethinyl estradiol) tablets because an impurity was detected during testing.

    Product
    BALZIVA — BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1684-2013·2013-07-17

    Baxter Recalls Arthroscopic Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1672-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheters Due to Incorrect Sheath Packaging

    Boston Scientific is recalling 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.

    Product
    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide