The Recall Desk

Hazard

Labeling Error recalls

209 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labeling error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

176–200 of 209

  • ModerateFDA (Devices)·Z-0802-2022·2022-03-23

    Calcium Alginate Wound Dressings Recalled for Incorrect Instructions

    CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.

    Product
    20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0804-2022·2022-03-23

    Calcium alginate wound dressings recalled for incorrect instruction labeling

    CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.

    Product
    20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0801-2022·2022-03-23

    Medical dressing recall issued due to incorrect instructions for use

    CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.

    Product
    20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error

    BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0679-2022·2022-03-09

    DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates

    Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.

    Product
    The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The var
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0636-2022·2022-03-09

    TSM Brands Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.

    Product
    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2022·2022-03-09

    70% Isopropyl Alcohol First Aid Antiseptic Contains Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.

    Product
    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0634-2022·2022-02-23

    Morphine Sulfate Syringe Recall Due to Labeling Mix-Up

    STAQ Pharma is recalling a limited number of syringes labeled as Morphine Sulfate PF that actually contain HYDROmorphone HCl PF due to a labeling error. The affected lot was distributed to Colorado, Ohio, and Texas.

    Product
    Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0633-2022·2022-02-23

    HYDROmorphone HCl syringe recalled due to labeling mix-up

    STAQ Pharma is recalling HYDROmorphone HCl PF syringes (lot 21104221A) that were incorrectly labeled as Morphine Sulfate PF. The mislabeling affects approximately 905 syringes distributed in Colorado, Ohio, and Texas.

    Product
    HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0650-2022·2022-02-23

    Merete PediatrOS RigidTack surgical device recalled for incorrect size label

    Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.

    Product
    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0544-2022·2022-02-09

    Medical device control product pouches mislabeled with incorrect catalog number

    Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.

    Product
    KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-0543-2022·2022-02-09

    Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling

    Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).

    Product
    KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0458-2022·2022-02-02

    CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride

    CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.

    Product
    CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2022·2022-01-26

    Infant Heel Warmers Recalled for Unauthorized Labeling Changes

    Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.

    Product
    Infant Heel Warmers w/strap, Reference # 989805603201 1223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0222-2022·2021-12-08

    Classic Irish Coffee Hint of Cocoa packets recalled for undeclared milk

    Trail Toddy & Company LLC is recalling Classic Irish Coffee Hint of Cocoa packets because milk is not declared on the label, though the product contains dairy ingredients. The recall affects products distributed in Illinois, Montana, and Massachusetts.

    Product
    Classic Irish Coffee Hint of Cocoa, each packet weighs 1.09 oz (31g), 30 packets per case. UPC 8 60003 91545 5. This product is a blend of shelf-stable ingredients and contains no alcohol. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, *COFFEE, COCOA PO
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0249-2022·2021-11-24

    Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0247-2022·2021-11-24

    VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information

    Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.

    Product
    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0092-2022·2021-11-10

    Methocarbamol Tablets Mislabeled with Incorrect Strength

    Bryant Ranch Prepack is recalling Methocarbamol 500mg tablets nationwide because the bottles are mislabeled—they actually contain 750mg tablets. The affected lot was distributed in 30-, 60-, and 90-count bottles.

    Product
    Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2022·2021-11-10

    Dental implants recalled for size mismatch with package labeling

    Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.

    Product
    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2022·2021-11-10

    Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling

    MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.

    Product
    Aspiration Syringe Kit, REF: MVSK60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0172-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0166-2022·2021-11-03

    GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date

    W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0163-2022·2021-11-03

    Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number

    Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.

    Product
    Pneupac paraPac plus 300 ventilator kit, REF P300NGB
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0019-2022·2021-10-27

    Rocuronium Bromide Injection Lacks Paralyzing Agent Warning

    Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.

    Product
    Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
    Category
    Drug
    Distribution
    Distributed nationwide