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.

2801–2825 of 21589

  • ModerateFDA (Devices)·Z-2032-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.

    Product
    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2036-2024·2024-06-19

    NEOMED nonsterile pharmacy syringes recalled for missing expiration dates on labels

    Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2024·2024-06-19

    Strep A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.

    Product
    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2024·2024-06-19

    NEOMED Oral Syringes Recalled Over Missing Expiration Dates on Labels

    Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2024·2024-06-19

    Medical device nerve block needles incorrectly labeled as DEHP-free

    Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2024·2024-06-12

    Surgical imaging device electrical component may intermittently shut off

    The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.

    Product
    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1286-2024·2024-06-12

    Charles Boggini Yellow Lemonade Recalled for Undeclared Yellow No. 5

    Charles Boggini Company is recalling Yellow Lemonade and Yellow Lemonade X (1 and 5 gallon sizes) due to undeclared FD&C Yellow No. 5. Consumers with tartrazine sensitivity should not consume the affected products.

    Product
    Charles Boggini Company Yellow Lemonade and Yellow Lemonade X; 1 gallon and 5 gallons
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1284-2024·2024-06-12

    Charles Boggini Pink Lemonade Recalled for Undeclared Food Dye

    Charles Boggini Pink Lemonade in 1 and 5-gallon sizes is recalled for containing undeclared FD&C Red No. 40. The colorant was not listed on product labels.

    Product
    Charles Boggini Pink Lemonde; 1 or 5 U.S. Gallons
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0537-2024·2024-06-12

    Cephalexin oral suspension recalled for incorrect label dosage amount

    Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0540-2024·2024-06-12

    Cephalexin oral suspension recalled for incorrect dose labeling

    Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2024·2024-06-12

    Estradiol Transdermal Patch Recalled for Failed Chemical Specifications

    Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2024·2024-06-12

    Quality Control Tool Vitamin B12 Range Verifier Recalled by FDA

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2024·2024-06-12

    Estradiol transdermal patches recalled for failed quality specifications

    Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2024·2024-06-12

    Cephalexin Oral Suspension Recalled for Incorrect Dosage Label

    Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1947-2024·2024-06-12

    Leica HistoCore PEGASUS tissue processor recalled for tissue damage

    LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.

    Product
    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0544-2024·2024-06-12

    TIVICAY HIV medication carton mislabeled with incorrect expiration date

    GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·24259·2024-06-06

    Wild Country Ropeman 1 Ascenders Recalled for Failure to Engage

    Salewa USA recalls Wild Country Ropeman 1 ascenders because the teeth can fail to engage, making it difficult or impossible to ascend. About 7,700 units sold in the United States since December 2022.

    Product
    Wild Country Ropeman 1 ascenders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2024·2024-06-05

    Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0523-2024·2024-06-05

    Aloe Gator SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredients

    ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2024·2024-06-05

    FDA recalls Pain Wizard topical pain relief for ingredient specification issues

    ARG Laboratories recalled Pain Wizard topical pain relief roll-on due to active ingredient out of specification and violative-grade propylene glycol used in manufacturing.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2024·2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2024·2024-06-05

    Pain Wizard topical pain relief recalled for out-of-specification manufacturing

    ARG Laboratories recalls Pain Wizard pain relief cream nationwide due to manufacturing defect involving propylene glycol that did not meet specifications.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2024·2024-06-05

    Mako robotic surgery system software error causes treatment delays

    Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24249·2024-05-30

    Black & Decker Recalls CRAFTSMAN V20 Cordless Tillers for Laceration Hazard

    Black & Decker is recalling about 44,400 CRAFTSMAN V20 Cordless Tillers/Cultivators because misleading assembly instructions can cause consumers to attach the tines upside down, creating a laceration hazard. No injuries have been reported.

    Product
    CRAFTSMAN® V20 Cordless Tillers/Cultivators
    Category
    Consumer Product
    Distribution
    Distributed nationwide