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.

926–950 of 3531

  • ModerateFDA (Devices)·Z-1344-2024·2024-03-27

    Guidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics

    Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1306-2024·2024-03-27

    Natus Sleep Supplies Recalled for Conductive Adhesive Gel Quality Defects

    Natus Neurology is recalling Sleep Supplies Start Kits due to defective conductive adhesive gel supplied by Parker Laboratories. The gel is too thick, discolored, and caused patient irritation in at least one case.

    Product
    natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2024·2024-03-27

    Liquid Protein Calibrators recalled for reference material realignment correction

    Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.

    Product
    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1305-2024·2024-03-27

    Conductive Adhesive Gel Recalled Due to Thickness and Discoloration Issues

    Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.

    Product
    TENSIVE Conductive Adhesive Gel, REF 016-401600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2024·2024-03-27

    Steris Endo Cleaning Indicator Recalled Due to Temperature Excursion

    Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.

    Product
    Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2024·2024-03-27

    Landauer microStar Reader dosimetry system discontinued for medical applications

    Landauer is permanently discontinuing the microStar Reader medical dosimetry system. The company is removing product documentation references and discontinuing use with medical dosimeters.

    Product
    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2024·2024-03-27

    Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect

    Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1339-2024·2024-03-27

    Angiodynamics surgical guidewire recalled for manufacturing defect

    Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2024·2024-03-27

    Medtronic DLP Vessel Cannula Recalled for Incorrect Labeling

    Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.

    Product
    Medtronic DLP Vessel Cannula, Model Number REF 30000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1063-2024·2024-03-20

    Banana Pepper Rings 16 FL OZ recalled for punctured jar lids

    Lidl US TRADING is recalling Banana Pepper Rings due to punctured lids on glass jars, which may compromise product integrity. Affected jars were distributed across multiple states in the Mid-Atlantic and Southeast regions.

    Product
    Banana Pepper Rings 16 FL OZ (1PT) 473ml UPC:4056489223863. Packaged in a glass jar with metal lid.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1287-2024·2024-03-20

    Aneurysm clips recalled due to incorrect blue coloring

    Peter Lazic Gmbh is recalling 170 L-Aneurysm Clip TITANIUM Paddle-Clips distributed in Maine due to incorrect blue coloring instead of blank.

    Product
    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0369-2024·2024-03-20

    Febuxostat tablets recalled due to microbial contamination in manufacturing

    Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2024·2024-03-20

    Broncochem Cold & Flu Syrup Kids Recalled Due to Stability Testing Failures

    Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.

    Product
    Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2024·2024-03-20

    BVI Visitec Irrigation Handle lacks manufacturing and expiration dates

    Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.

    Product
    BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1061-2024·2024-03-20

    Vitony Bakery Cheesecake Recalled for Undeclared Food Dyes

    Vitony Bakery cheesecake products are being recalled due to undeclared FD&C Yellow #5 and Yellow #6 dyes. The recall affects 6,916 units distributed to Puerto Rico and may pose risks to consumers with sensitivities to these colorants.

    Product
    Vitony Bakery, Bizcocho de Queso (cheesecake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1064-2024·2024-03-20

    Electric City Sweets Chocolate Bars Recalled for Undeclared Milk

    Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bars are being recalled because milk is not properly declared on the packaging. The recall affects 1,644 bars distributed in California, Florida, Pennsylvania, and North Carolina.

    Product
    Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bar. Individually wrapped in paper/foil packaging.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2024·2024-03-20

    FDA Recalls Broncochem Cold & Tea Nationwide for Stability Failures

    Global Corporation is recalling Broncochem Cold & Tea nationwide due to stability testing failures in the active ingredients. No illnesses or injuries have been reported.

    Product
    BRONCOCHEM — BRONCOCHEM (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1298-2024·2024-03-20

    Hip prosthesis labeling clarification needed to prevent surgical confusion

    Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.

    Product
    SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24160·2024-03-14

    Tracker Off Road OX EV Light Utility Vehicles Recalled for Fire Hazard

    About 500 Tracker Off Road OX EV vehicles are being recalled due to water entering the lithium-ion battery pack, which can cause a fire. No injuries have been reported.

    Product
    Tracker Off Road OX EV Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2024·2024-03-13

    Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications

    Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.

    Product
    Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2024·2024-03-13

    Frios Gourmet Pops Fruity Pebbles popsicles recalled for undeclared Yellow #5

    Frios Gourmet Pops Fruity Pebbles Popsicles are being recalled due to undeclared Yellow #5 color additive. Consumers with sensitivity or allergy to tartrazine should not consume the product.

    Product
    Frios Gourmet Pops - Fruity Pebbles Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide