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.

15001–15025 of 21645

  • ModerateFDA (Food)·F-0813-2016·2016-04-06

    Ventura Foods Recalls Cooking Oil Jugs Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of cooking oil because plastic fragments may be present due to a manufacturing defect in the jugs.

    Product
    45532-CHP: Chef's Pride Soybean Clear Fry Oil 35 lb.; 54135-CHP: Chef's Pride Soybean Salad Oil 35 lb.; 45635-CHP: Chef's Pride Soybean Pan & Grill Frying Oil 35 lb.; 54135-TXR: Texas Roadhouse Soybean Salad Oil 35 lb.; 54135-PAD: Panda Express Soybean Salad Oil 35 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2016·2016-04-06

    Siemens E.CAM Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.

    Product
    The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2016·2016-04-06

    Biomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle

    Biomet Spine is recalling specific Solitaire Ti Spacers because they are mislabeled as having a 12-degree lordotic angle when the actual angle is 6 degrees.

    Product
    10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2016·2016-04-06

    Siemens Artis One X-Ray System Recalled for Data Mirroring Error

    Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.

    Product
    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1263-2016·2016-04-06

    Siemens Symbia Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.

    Product
    The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0782-2016·2016-04-06

    Praxair Recalls 127 Cylinders of Compressed Medical Air Due to Odor

    Praxair Inc. is recalling 127 cylinders of compressed medical air because a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0814-2016·2016-04-06

    Ventura Foods Recalls Canola Frying Oil Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of canola frying oil because plastic from the jug's sealing surface may have been pushed into the product during manufacturing.

    Product
    18159-BLN : Brilliance Clear Zero Premium Clear Canola Frying Oil 35 lb. ; 58503-CHP : Chef's Pride Canola Clear Fry Oil 35 lb. ; 58503-FLV : Flavorite Canola Clear Fry Oil 35 lb. ; 58503-PLF : Planet Fry Canola Clear Fry Oil 35 lb. ; 58503-NGT : Nugget Brand Canola Clear…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2016·2016-04-06

    Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

    Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1001-2016·2016-04-06

    ProSupps Recalls Mr. Hyde Pre-Workout for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling 33 units of Mr. Hyde Intense Energy Pre-Workout because the product may contain undeclared Picamilon.

    Product
    Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS BLUERAZZ NATURAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 3.7 OZ (105 GRAMS) packaged in red plastic jars with black lids.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2016·2016-04-06

    Molteno3 Glaucoma Implants Recalled for Updated Instructions

    Innovative Ophthalmic Products is recalling Molteno3 Glaucoma Implants because the package insert was updated to add a caution statement to minimize off-label use.

    Product
    Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2016·2016-04-06

    Beckman Coulter Recalls MicroScan LabPro Software Due to Editing Error

    Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.

    Product
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1268-2016·2016-04-06

    Pelton & Crane Recalls Helios Track Mounted Dental Lights

    Pelton & Crane is recalling 156 Helios HL3T and HLT track mounted dental lights because they were missing two set screws during initial installation.

    Product
    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2016·2016-04-06

    Wfr/aquaplast Recalls Prone Breast Treatment Tables Due to Scale Misalignment

    Wfr/aquaplast Corp is recalling 30 prone breast treatment tables and devices because some may have misaligned scales, potentially causing orientation differences.

    Product
    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0785-2016·2016-04-06

    Safecor Health Recalls Donnatal Elixir Due to Labeling Error

    Safecor Health is recalling 23 cups of Donnatal Elixir because the label incorrectly lists the dose as 5 ml instead of 10 ml.

    Product
    Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1239-2016·2016-03-30

    CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

    CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

    Product
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1175-2016·2016-03-30

    Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure

    Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.

    Product
    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0774-2016·2016-03-30

    King Henry's Recalls Fruit and Nut Medley for Undeclared Dye

    King Henry's, Inc. is recalling Fruit & Nut Medley because it may contain undeclared FD&C Yellow #6. The recall covers 3,242 units distributed across 25 US states and British Columbia.

    Product
    Fruit & Nut Medley, Snacks Fit for a King, King Size, 12 per case. NP- UPC 61054645419 and 61054645119.
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1243-2016·2016-03-30

    Siemens IMMULITE 2000 Estradiol Test Recalled Due to Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol Test kits because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

    Product
    IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0806-2016·2016-03-30

    Fabi-Saa Mote Blanco Recalled for Undeclared Sulfites

    FABI - SAA Inc. is recalling Fabi-Saa Mote Blanco due to undeclared sulfites. The product was distributed in New York and New Jersey.

    Product
    Fabi-Saa Mote Blanco Net Wt. 14 oz. (397 g) Imported and Distributed by Fabi-Saa Inc. Belleville, NJ 07109 UPC 874093000090 Made in USA
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1189-2016·2016-03-30

    Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

    Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

    Product
    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0779-2016·2016-03-30

    AGA Gas Recalls Bulk Liquid Oxygen Due to GMP Deviations

    AGA Gas Inc is recalling 1,500 gallons of bulk liquid oxygen because the delivery trailer may not have met GMP requirements prior to filling.

    Product
    Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0781-2016·2016-03-30

    AstraZeneca Recalls Tudorza Pressair Inhalers Due to Defective Delivery System

    AstraZeneca is recalling Tudorza Pressair inhalers because some units have actuation counters set to a number other than 60.

    Product
    Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2016·2016-03-30

    Roche cobas p 512 Pre-analytical System Recalled for Sample Spillage

    Roche is recalling 35 cobas p 512 pre-analytical systems because a sensor defect causes open sample tubes to drop and spill.

    Product
    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1234-2016·2016-03-30

    Medtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance

    Medtronic Navigation is recalling four BioTex Reusable Adapter Kits because they were distributed without FDA 510(k) clearance.

    Product
    BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1235-2016·2016-03-30

    AcuFocus Recalls KAMRA Corneal Inlays Due to Shelf Life Labeling Concerns

    AcuFocus is recalling 182 KAMRA ACI 7000 Corneal Inlays because of concerns regarding the labeled shelf life. The devices were distributed in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.

    Product
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
    Category
    Medical Device
    Distribution
    0 states