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.

13401–13425 of 21617

  • ModerateFDA (Devices)·Z-0382-2017·2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization

    Teleflex Medical is recalling Flexi Nozzle Long sprayers because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0895-2017·2016-12-28

    Busse Breast Pack Surgical Instrument Tray Recalled for Labeling Update

    Busse Hospital Disposables is recalling Breast Pack Surgical Instrument Trays because they contained gloves subject to a labeling update.

    Product
    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0845-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling a limited number of Low Profile 30-degree abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0883-2017·2016-12-28

    Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects

    Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.

    Product
    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0760-2017·2016-12-28

    Real Fudge White Fudge Recalled for Undeclared Blue #1

    Real Fudge is recalling 8 oz units of White Fudge because the product contains undeclared Blue #1 dye.

    Product
    White Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0761-2017·2016-12-28

    Real Fudge Coconut Fudge Recalled for Undeclared Blue #1 Dye

    Real Fudge is recalling 8 oz. Coconut Fudge containers due to undeclared Blue #1 dye. The product was distributed in five states.

    Product
    Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0874-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2017·2016-12-28

    Synthes VA Implant Rack Recalled for Incorrect Assembly

    Synthes (USA) Products LLC is recalling 31 units of the VA Implant Rack for the Compact Distal Radius System because incorrect assembly could cause screws to touch the surface beneath the rack.

    Product
    Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2017·2016-12-28

    Ultroid Mobile Generator and Sterile Probes Recalled for Quality System Failures

    Ultroid Technologies is recalling 62 mobile generator units and sterile probes because they were not manufactured under required quality system controls.

    Product
    Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-0894-2017·2016-12-28

    Busse Carpal Tunnel Surgical Packs Recalled Due to Labeling Update

    Busse Hospital Disposables is recalling Carpal Tunnel Packs because they contained Devon Light Gloves subject to a labeling update.

    Product
    CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0864-2017·2016-12-28

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.

    Product
    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0859-2017·2016-12-28

    Biomet 3i Low Profile Abutment Quickbridge Recall for Unsealed Pouches

    Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0770-2017·2016-12-21

    Natus neoBLUE blanket LED Phototherapy System Recalled for Fiber Optic Degradation

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to discoloration and degradation of the fiberoptic bundle at the pad and box connection.

    Product
    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0748-2017·2016-12-21

    Ellman Minor Surgery Bipolar Cable Recalled for Mismatched Expiration Dates

    Ellman International is recalling 370 boxes of Minor Surgery Bipolar Cables because the expiration dates on the outer boxes and individual pouches do not match.

    Product
    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0715-2017·2016-12-21

    H-E-B Recalls Baby Banana Carrot Mango Cups Due to Rubber Piece

    H-E-B is recalling specific lots of Baby Banana Carrot Mango cups after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Banana Carrot Mango 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0768-2017·2016-12-21

    Beckman Coulter Recalls MicroScan LabPro Data Management System Software

    Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

    Product
    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0730-2017·2016-12-21

    Merge Cardio software recall for data loss during inactivity

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.

    Product
    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0683-2017·2016-12-21

    Galliker's Lemon Iced Tea Recalled for Missing Pasteurization Documentation

    Galliker Dairy Co. is recalling 2,851 gallon jugs of lemon iced tea because the products were labeled as pasteurized without legal documentation to support the claim.

    Product
    Galliker's Lemon Iced Tea Flavored, 1 GAL and Galliker's Lemon Flavored Iced Tea, 1/2 GAL
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0758-2017·2016-12-21

    Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects

    Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.

    Product
    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-0744-2017·2016-12-21

    Cargill Recalls Butter Flavored Oil Due to Excessive Additives

    Cargill is recalling 1-gallon bottles of refyne Butter Flavored Oil because they contain excessive amounts of TBHQ and dimethyl polysiloxane.

    Product
    refyne Artificially Flavored BUTTER FLAVORED OIL, NET CONTENTS 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL,***TBHQ--- Dimethylpolysiloxane***CONTAINS: SOY., UPC 0 41560 13659 4
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Food)·F-0712-2017·2016-12-21

    H-E-B Recalls Baby Pear Carrot Blueberry Cups Due to Foreign Object

    H-E-B is recalling specific lots of Baby Pear Carrot Blueberry cups after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Pear Carrot Blueberry 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0743-2017·2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed 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-0735-2017·2016-12-21

    C.R. Bard Recalls 70cc Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect may compromise product sterility.

    Product
    BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0722-2017·2016-12-21

    Wegmans Milk Chocolate Covered Pretzels Recalled for Incorrect Labeling

    First Source, LLC is recalling Wegmans Milk Chocolate Covered Pretzels because the rear label is incorrect and lacks allergen declarations.

    Product
    Wegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g)
    Category
    Food
    Distribution
    6 states