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.

21226–21250 of 21633

  • ModerateFDA (Devices)·Z-2453-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Software Recall for Image Orientation Errors

    Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters

    Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1695-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Container Wall Defect

    Abbott Laboratories is recalling 42,596 bottles of Synthroid (levothyroxine sodium) 75 mcg tablets due to a localized thin wall defect on the bottle bottom that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2012·2012-10-03

    Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads

    Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.

    Product
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2437-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage Concerns

    Pulmuone Wildwood Inc. is recalling 781 units of Wildwood Emerald Valley Kitchen Organic Mild Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1696-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1687-2012·2012-10-03

    Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2435-2012·2012-10-03

    Pulmuone Wildwood Organic Hot Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 3,148 units of Wildwood Emerald Valley Kitchen Organic Hot Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA***NET WT. 14 OZ (850g)***MANUFACTURED…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Pod Recall for False Alarms

    Terumo is recalling 150 Advanced Perfusion System 1 Flow Pods due to a circuit board defect that causes false back flow alarms when tubing is absent.

    Product
    Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1691-2012·2012-10-03

    Dispensing Solutions Recalls Atrovent HFA Inhalers Due to Label Error

    Dispensing Solutions, Inc. is recalling 18 Atrovent HFA inhalers because a sticker label incorrectly identifies the product as Ventolin HFA.

    Product
    Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1690-2012·2012-10-03

    Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

    Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2446-2012·2012-10-03

    Applied Medical Recalls Vascular Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of Vascular Catheters because packaging particulate matter may reside on the product.

    Product
    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2433-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc is recalling Wildwood Emerald Valley Kitchen Organic Medium Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2467-2012·2012-10-03

    K-Y Liquibeads Vaginal Moisturizer Recalled for Regulatory Compliance

    Johnson & Johnson is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns regarding the product's medical device clearance status.

    Product
    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1694-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) 50 mcg tablets nationwide due to a defect in the bottle bottom that may affect tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1701-2012·2012-10-03

    Glenmark Recalls Naproxen Sodium Tablets Due to Labeling Error

    Glenmark Generics is recalling Naproxen Sodium 500 mg tablets because some bottles may contain Pravastatin Sodium 40 mg tablets.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.

    Product
    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2438-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage Concerns

    Pulmuone Wildwood Inc is recalling 602 units of Wildwood Organic Mild Salsa due to a potential non-safety quality concern involving an ingredient that causes premature spoilage.

    Product
    Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2012·2012-10-03

    Applied Medical Recalls Irrigation Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of irrigation catheters because packaging particulate matter may reside on the product.

    Product
    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2012·2012-10-03

    Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues

    Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.

    Product
    Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2471-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters

    Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2012·2012-10-03

    RaySearch SharePlan Software Recalled for Unexpected Import Behavior

    RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.

    Product
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1685-2012·2012-10-03

    Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter

    Hospira Inc. is recalling 148,630 vials of Propofol Injectable Emulsion because a single visible particulate was found in sample bottles during inspection.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2439-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc is recalling 748 units of Wildwood Organic Medium Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA…
    Category
    Food
    Distribution
    Distributed nationwide