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.

4076–4100 of 21589

  • ModerateFDA (Devices)·Z-0220-2023·2022-11-16

    Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.

    Product
    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0196-2023·2022-11-16

    Alphatec Spine Disc Preparation Instruments Recalled for Regulatory Non-Compliance

    Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.

    Product
    Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-1105
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0181-2023·2022-11-16

    Dialysis concentrate labeling error for chemical composition

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.

    Product
    NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-0134-2023·2022-11-16

    Pomegranate Fruit Roll Ups recalled for higher sodium content than labeled

    Shemshad Food Products, Inc. is recalling Pomegranate Fruit Roll Ups due to sodium content measured at 131% of the declared level. The product was distributed to 8 retail locations in the Los Angeles area.

    Product
    2 oz. units of Pomegranate Fruit Roll Ups in boxes of 24, sold as individual units. Ingredients: Apple, Pomegranate, Water Sugar, Citric Acid, Salt. UPC: 0 84613 13066 8 Product of USA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0192-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use

    Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.

    Product
    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23041·2022-11-10

    Hunter Fan Recalls Five Lighting Collections Due to Electric Shock Hazard

    Hunter Fan Company is recalling approximately 2,600 light fixtures from five collections because internal wires can become damaged, posing an electric shock hazard. Consumers should stop using the products immediately and contact Hunter for a full refund.

    Product
    Hunter branded Devon Park, Astwood, Highland Hill, Kerrison and Van Nuys light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    Ranibizumab eye implant recalled for non-functioning delivery system

    Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0079-2023·2022-11-02

    The Chai Box Chai Concentrate Recalled for Botulinum Contamination

    The Chai Box Chai Concentrate is being recalled due to potential Clostridium botulinum contamination identified during testing. Affected products have best-by dates from September 2022 to March 2023.

    Product
    THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glass bottles UPC 7 93611 81925 2 REGRIGERATE AFTER OPENING. USE WITHIN 14 DAYS and 64FL OZ/1892ML plastic bottles KEEP REFRIGERATED USE WITHIN 7 DAYS OF OPENING UPC 7 93611 81926 9. INGREDIENTS Water, Black Teas, Spices - C
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0121-2023·2022-11-02

    Medline Peripheral Blood Culture Draw Kit Recall: Incorrect Expiration Dates

    Medline is recalling 1,020 peripheral blood culture draw kits due to incorrect expiration dates on kit components. The CHG solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit.

    Product
    MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2023·2022-11-02

    EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up

    Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.

    Product
    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2023·2022-11-02

    Medline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates

    Medline recalls Adult Blood Culture Collection Kits due to incorrect expiration dates on kit components. The expiration dates on the CHG Solution and Bactec bottle plastic do not match the dates listed on the kit packaging.

    Product
    MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2023·2022-11-02

    ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction

    ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2023·2022-11-02

    LumiraDx SARS-CoV-2 Quality Control Kit: Incorrect Lot Numbers

    LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (batch 2002204017) with incorrect vial lot numbers. The kits contain Flu A/B lot numbers instead of SARS-CoV-2 Ag numbers, causing error messages and preventing device use.

    Product
    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2023·2022-11-02

    Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates

    Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.

    Product
    MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·22T020000·2022-10-28

    Yokohama Recalls Tires with Incorrect Date Codes on Sidewalls

    Yokohama Off-Highway Tires America is recalling specific tires because the date code on the sidewall is incorrect, which hinders age identification.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2023·2022-10-26

    FDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities

    Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution nationwide because the product contains impurities that exceed acceptable limits. The recall affects two lots distributed across the United States.

    Product
    FLUNISOLIDE — FLUNISOLIDE (FLUNISOLIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0055-2023·2022-10-26

    Lyons Ready Care Thickened Cranberry Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Cranberry Nectar due to indication of product spoilage. Approximately 999 cases were distributed across all U.S. states.

    Product
    Lyons Ready Care Thickened Cranberry Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Food)·F-0056-2023·2022-10-26

    Lyons Ready Care Thickened Cranberry Honey Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Cranberry Honey Nectar due to indication of product spoilage. The recall involves 468 cases distributed across 49 states.

    Product
    Lyons Ready Care Thickened Cranberry Honey Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Food)·F-0042-2023·2022-10-26

    Turner's Cottage Cheese Recalled for Bacterial Spoilage

    Titusville Dairy Products Co. is recalling Turner's Apple Cinnamon Whole Milk Cottage Cheese (5.3oz) due to bacterial spoilage. The affected products were distributed to a direct consignee in Pennsylvania.

    Product
    Turner's Apple Cinnamon Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300169
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0059-2023·2022-10-26

    Imperial Thickened Orange Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Imperial Thickened Orange Nectar due to indication of product spoilage. The 46 fl oz cartons were distributed nationwide.

    Product
    Imperial Thickened Orange Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Food)·F-0041-2023·2022-10-26

    Turner's Pineapple Cottage Cheese Recalled for Bacterial Spoilage

    Turner's Pineapple Whole Milk Cottage Cheese 5.3oz is being recalled due to potential bacterial spoilage. The product was distributed in Pennsylvania; affected consumers should discard it.

    Product
    Turner's Pineapple Whole Milk Cottage Cheese 5.3oz. (150g) UPC:3573300168
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0108-2023·2022-10-26

    Medicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material

    Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.

    Product
    Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2023·2022-10-26

    OTC Sinus Pressure and Pain Cough Product Mislabeled as Decongestant-Free

    Walgreens Sinus Pressure, Pain & Cough tablets are mislabeled as 'Decongestant Free' but contain Phenylephrine HCl, a nasal decongestant. The labeling error affects 66,384 boxes distributed nationwide.

    Product
    SINUS PRESSURE, PAIN AND COUGH — SINUS PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide