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.

15726–15750 of 21645

  • ModerateFDA (Drugs)·D-0015-2016·2015-10-21

    Ferring Recalls Bravelle 75 IU Vials Due to Subpotent Drug

    Ferring Pharmaceuticals is recalling 32,341 vials of Bravelle 75 IU because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·127-2015·2015-10-18

    Good Food Concepts Recalls Beef, Pork, and Poultry Products for HACCP and Labeling Issues

    Good Food Concepts is recalling approximately 12,566 pounds of beef, pork, and poultry products produced without a fully implemented HACCP plan and misbranded with undeclared sodium nitrite.

    Product
    Good Food Concepts, LLC — Good Food Concepts Recalls Beef, Pork, and Poultry Products Produced Without a Fully Implemented HACCP Plan, and Misbranded
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0003-2016·2015-10-14

    Organic Girl Baby Spinach Recalled for Elevated Cadmium Levels

    NewStar Fresh Foods is recalling Organic Girl baby spinach due to elevated cadmium levels. The product was distributed in 12 states.

    Product
    organic girl - good clean greens baby spinach - tender nutrition baby leaves. Washed 3 times. USDA Organic. 5 oz.. plastic clamshell. Distributed by organic girl, Salinas, CA 93901
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0024-2016·2015-10-14

    Synthes Periarticular Insertion Handles and Aiming Arms Recalled for Fit Issues

    Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Aiming Arms because they cannot be secured to subsequent device versions as intended.

    Product
    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0105-2016·2015-10-14

    CooperSurgical LEEP REDIKIT Recalled for Incorrect Lidocaine Concentration Labeling

    CooperSurgical is recalling LEEP REDIKIT surgical kits because the labels list 2% Lidocaine HCl, but the kits contain 1% Lidocaine HCl vials.

    Product
    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0022-2016·2015-10-14

    Medtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status

    Medtronic is recalling 777 identification cards for SureScan pacemaker patients that incorrectly indicate the entire system is MR Conditional.

    Product
    Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2016·2015-10-14

    Siemens SOMATOM Definition Flash CT Scanner Software Recall

    Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.

    Product
    SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0025-2016·2015-10-14

    Integra Recalls Universal Compact Head Ring Adapter Plate Due to Assembly Error

    Integra LifeSciences Corp. is recalling six Universal Compact Head Ring Adapter Plates that do not assemble properly due to a manufacturing drawing error.

    Product
    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0106-2016·2015-10-14

    Siemens Syngo RT Oncologist software update addresses safety issues

    Siemens Medical Solutions is updating Syngo RT Oncologist software versions 4.2 and 4.3 to fix safety and performance issues.

    Product
    Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0021-2016·2015-10-14

    Siemens SOMATOM Definition AS CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2016·2015-10-14

    Zimmer Universal Locking System Recalled for Incorrect Silk Screening

    Zimmer, Inc. is recalling 18 units of the Universal Locking System due to incorrect catalog numbers printed on the trays.

    Product
    Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0023-2016·2015-10-14

    GE Healthcare Recalls Centricity PACS IW Due to Missing Images

    GE Healthcare is recalling 921 Centricity PACS IW systems worldwide because images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.

    Product
    MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2016·2015-10-14

    Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors

    Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.

    Product
    Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2016·2015-10-14

    Toshiba Recalls Celesteion PET/CT Systems Due to Data Loss Risk

    Toshiba American Medical Systems is recalling one Celesteion PCA-9000A/2 PET/CT System in Nevada because a software defect may prevent raw data from being saved during specific scans.

    Product
    Celesteion PCA-9000A/2 PET/CT System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0019-2016·2015-10-14

    Siemens SOMATOM Definition Edge CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0008-2016·2015-10-14

    Daytrana Methylphenidate Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) 30 mg patches due to a defective delivery system that failed mechanical peel force specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3250-2015·2015-10-07

    Sun Kee Mixed Fruit Candy Recalled for Undeclared Dyes

    Prosperity Resources is recalling Sun Kee Mixed Fruit Candy because it contains undeclared colors and an unallowable dye.

    Product
    Mixed Fruit Candy, Net Wt. 12 oz. (340g), Distributed by: Prosperity Resources Int'l, Inc., Product of China, UPC 6 47406 02091 3
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-3258-2015·2015-10-07

    Coquette's Gluten Free Cupcakes Recalled for Incorrect Allergen Labeling

    Coquette's Bistro and Bakery is recalling 120 packages of gluten-free cupcakes because the label incorrectly states the product contains no egg or dairy, despite containing both.

    Product
    Coquette's Gluten Free Spring Pack Cupcakes (4 pack), Oranges n' Cream & Strawberry Mint Lemonade. coquettesbistro.com. NET Wt. 9.67 OZ. No expiration date on package, sold in ambient air at retail.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2820-2015·2015-10-07

    Zimmer Recalls Guide Wires Due to Incorrect Expiration Date Labeling

    Zimmer, Inc. is recalling 112,568 sterile guide wires because the labels state a 10-year expiration date, while testing supports only 5 years.

    Product
    Zimmer Guide Wires for orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2016·2015-10-07

    Lifeline Systems Recalls Philips GoSafe Mobile Help Button Due to Battery Issues

    Lifeline Systems is recalling 8,616 Philips GoSafe Mobile Help Button devices because irregular battery disconnection can cause charging issues.

    Product
    Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2016·2015-10-07

    Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation

    Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution compact foundation because the salicylic acid ingredient is subpotent.

    Product
    Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2015·2015-10-07

    Sterilmed Recalls Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling

    Sterilmed is recalling 43 reprocessed Zimmer tourniquet cuffs because they are labeled as single hose but are actually dual hose devices.

    Product
    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0001-2016·2015-10-07

    Guthy-Renker Recalls Rodan & Fields Proactiv Foundation for Subpotent Salicylic Acid

    Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.

    Product
    Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2015·2015-10-07

    Olympus Recalls Gastrovideoscope Due to Insufficient Cleaning Accessory Information

    Olympus is recalling 1,014 EVIS EXERA II Gastrovideoscopes because specific cleaning accessories required for reprocessing were not provided.

    Product
    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide