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.

9801–9825 of 21595

  • ModerateFDA (Devices)·Z-0227-2019·2018-10-31

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.

    Product
    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0070-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls Hummus Due to Foreign Material

    Cedar's Mediterranean Foods is recalling Central Market All Natural Traditional Hummus because the product contains foreign material. The recall affects 37,521 units distributed in Texas.

    Product
    Central Market All Natural Traditional Hummus TOPPED WITH SESAME SEEDS, NET WT 10 OZ (284g).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0219-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0281-2019·2018-10-31

    Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

    Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

    Product
    BUMETANIDE — BUMETANIDE (BUMETANIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0077-2019·2018-10-24

    Rexall Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0061-2019·2018-10-24

    Walgreens NO DRIP Anefrin Nasal Spray recall due to CGMP deviations

    This FDA drug recall affects Walgreens NO DRIP Anefrin nasal spray due to current good manufacturing practice deviations that could impact product quality.

    Product
    Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2019·2018-10-24

    FDA Recalls Premier Value Nasal Spray Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray because it was manufactured under conditions that could impact product quality.

    Product
    Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0076-2019·2018-10-24

    Rexall Sinus Nasal Pump Mist Recalled for Quality Control Issues

    Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist due to manufacturing deviations that could impact product quality.

    Product
    Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0080-2019·2018-10-24

    Product Quest Recalls Family Dollar Saline Nasal Spray for Quality Issues

    Product Quest Manufacturing LLC is recalling Family Dollar Saline Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0036-2019·2018-10-24

    K.B. Pizza Recalls Son of Italy Pizza Kits Due to Temperature Abuse

    K.B. Pizza, Inc. is recalling Son of Italy pizza kits because they were left at room temperature for 24 hours.

    Product
    Son of Italy Pepperoni Pizza Kit ,39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2019·2018-10-24

    Finafta Baby Oral Gel Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Finafta Baby Oral Gel because it was manufactured under conditions that could impact product quality.

    Product
    Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2019·2018-10-24

    Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) powder because it has inconsistent levels of levothyroxine and liothyronine.

    Product
    Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 units of Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2019·2018-10-24

    Affixus Hip Fracture Nails Recalled Due to Compromised Sterile Packaging

    The FDA is recalling 72 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, creating a potential contamination risk.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0022-2019·2018-10-24

    Humco Recalls Thyroid USP Powder Due to Inconsistent Active Ingredient Levels

    Humco Holding Group, Inc. is recalling specific lots of Thyroid, USP (Porcine) powder because the levels of active ingredients are inconsistent.

    Product
    Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2019·2018-10-24

    CryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error

    CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.

    Product
    CryoPatch SG Pulmonary Hemi-Artery, 1 graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2019·2018-10-24

    Cypress Medical Recalls McKesson Insulin Syringes Due to Suction Defect

    Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.

    Product
    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2019·2018-10-24

    Baxter Spectrum IQ Infusion System Recalled for Programming Error

    Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.

    Product
    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0146-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 78 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide