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.

17801–17825 of 21645

  • ModerateFDA (Devices)·Z-2688-2014·2014-10-01

    Smith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems

    Smith & Nephew is recalling RENASYS EZ Negative Pressure Wound Therapy Systems because modifications were made without required FDA notifications.

    Product
    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2487-2014·2014-10-01

    Dairy Farmers of America Recalls Raw Milk for Sulfamethazine

    Dairy Farmers of America is recalling raw milk that tested positive for the antibiotic sulfamethazine. The milk was distributed to processors in Ohio, Illinois, Missouri, and Michigan.

    Product
    Raw Milk (Bulk; approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1604-2014·2014-10-01

    Hospira Recalls Buprenorphine Hydrochloride Injection Due to Impurity Failure

    Hospira Inc. is recalling specific lots of Buprenorphine Hydrochloride Injection because the product failed impurity specifications during stability testing.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2645-2014·2014-09-24

    FDA Recalls Ultraslim Devices for Marketing Without Clearance

    Advanced Photonic Systems is recalling 235 Ultraslim devices because they were marketed without FDA clearance or approval.

    Product
    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2648-2014·2014-09-24

    Bard DuaLok Breast Lesion Localization Wire Recalled for Sterile Barrier Breach

    Bard Peripheral Vascular Inc is recalling Bard DuaLok Breast Lesion Localization Wires because portions of the wire may protrude from the packaging, breaching the sterile barrier.

    Product
    Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2663-2014·2014-09-24

    Siemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues

    Siemens Healthcare Diagnostics is correcting ADVIA Centaur and XP systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2449-2014·2014-09-24

    Dannon Activia Yogurt Recalled for Potential Antibiotic Contamination

    Dannon is recalling Activia Lowfat Blueberry Yogurt because it may contain condensed skim milk produced from raw milk testing positive for sulfamethazine.

    Product
    Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2647-2014·2014-09-24

    FDA Recalls Photonica Light Modulator for Marketing Without Clearance

    Advanced Photonic Systems is recalling 235 Photonica Light Modulator units because they were marketed without FDA clearance or approval.

    Product
    Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding.…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2640-2014·2014-09-24

    Amerx Recalls Amerigel Post-Op Surgical Kits for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amerigel Post-Op Surgical Kits because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2482-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Winter Squash Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Winter Squash with Pecan Pralines frozen dessert because the packaging does not list ingredients.

    Product
    Winter Squash with Pecan Pralines- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2665-2014·2014-09-24

    Siemens CentraLink Data Management System Software Recall for Timer Overflow

    Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

    Product
    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2668-2014·2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2455-2014·2014-09-24

    Jenis Cassis Sorbet Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Cassis Sorbet because the frozen dessert labels do not list ingredients. The product was distributed to all 50 states.

    Product
    Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2666-2014·2014-09-24

    Philips Brilliance CT Big Bore Recalled for Emergency Stop Defect

    Philips Medical Systems is recalling 257 Brilliance CT Big Bore systems because the emergency stop function may activate while the system is idle, halting all movements and scans.

    Product
    The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1584-2014·2014-09-24

    Taro Recalls Warfarin Sodium Tablets Due to Content Uniformity Failures

    Taro Pharmaceuticals is recalling specific lots of Warfarin Sodium tablets because they failed content uniformity specifications. The affected products were distributed in seven US states.

    Product
    WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Food)·F-2477-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Strawberry Sorbet for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Strawberry Sorbet because the frozen dessert lacks ingredient information on the label.

    Product
    Strawberry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2458-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Violet frozen desserts because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2466-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Lapsang Souchong with Armagnac Prumes frozen desserts because the packaging does not list ingredients.

    Product
    Lapsang Souchong with Armagnac Prumes- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2473-2014·2014-09-24

    Jenis Savannah Buttermint Frozen Dessert Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Savannah Buttermint frozen dessert because the packaging does not list ingredients.

    Product
    Savannah Buttermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2656-2014·2014-09-24

    Zenith Slide W-I-D-E Long Term Care Bed Recall for Head Deck Failure

    GF Health Products is recalling 1,941 Zenith Slide W-I-D-E Long Term Care Beds because the head deck may fail to elevate during normal operation.

    Product
    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2474-2014·2014-09-24

    Jenis Spiced Pecan Praline Frozen Dessert Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Spiced Pecan Praline frozen desserts because the packaging does not list ingredients.

    Product
    Spiced Pecan Praline- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2664-2014·2014-09-24

    Philips CT Systems Recalled for Software Image Overlap Defect

    Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.

    Product
    The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2630-2014·2014-09-24

    Fresenius Recalls BD Vacutainer EDTA Tubes Due to Improper Storage

    Fresenius Medical Care is recalling 26 boxes of BD Vacutainer EDTA tubes held at improper storage temperatures. The affected lots were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2467-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Lime Cardamom Frozen Dessert for Labeling Defect

    Jenis Splendid Ice Creams LLC is recalling Lime Cardamom with Lingonberries frozen dessert because the product labeling does not include ingredients.

    Product
    Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2667-2014·2014-09-24

    Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes

    Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.

    Product
    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide