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.

76–100 of 209

  • HighFDA (Devices)·Z-1901-2024·2024-06-05

    Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch

    Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.

    Product
    smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1544-2024·2024-04-24

    Neria Soft Infusion Sets recalled due to incorrect instruction manual

    Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.

    Product
    Neria Soft Infusion Set, Product Code 507302, intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2024·2024-04-17

    Olympus Hemostasis Probe Mispackaged with Wrong Connector Type

    Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.

    Product
    Hemostasis Probe, Model: CD-B622LA
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1097-2024·2024-04-03

    Bluebonnet Methylfolate Chewables Recalled for Label Unit Error

    Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.

    Product
    EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1299-2024·2024-03-20

    SPII Lubinus Hip Prosthesis Recalled Due to Carton Label Interpretation Guidance

    Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.

    Product
    SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2024·2024-02-28

    Voriconazole Oral Suspension Recalled for Missing Package Insert

    Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0985-2024·2024-02-14

    Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions

    CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.

    Product
    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2024·2024-02-07

    Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates

    Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.

    Product
    MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2024·2024-02-07

    Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert

    Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Expired Bactec Component

    Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2024·2024-02-07

    Surgical needle holders distributed with incorrect product labels

    Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.

    Product
    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0659-2024·2024-01-17

    Baxter Vascular Probe Marketed with Inaccurate Prescribing Information

    Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.

    Product
    Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 74
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0626-2024·2024-01-10

    Patella implant component recalled due to labeling error

    Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.

    Product
    REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2024·2023-12-27

    Nystatin Bulk Powder Recalled Due to Incorrect Label Strength

    Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.

    Product
    NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0528-2024·2023-12-20

    Sterile PVP Medical Solution Recalled for Non-Sterile Contents

    Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.

    Product
    STERILE PVP, REF DYNDA1649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled

    Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error

    Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2024·2023-11-29

    DBX Demineralized Bone Matrix Putty fill volume mislabeled

    DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.

    Product
    DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0412-2024·2023-11-22

    Shrimp Recall Due to Undeclared Red Food Dye

    EL CHILAR natural shrimp (2 oz packages, Lot F-219) recalled due to undeclared Red #40 food coloring. The product was voluntarily withdrawn from domestic distribution.

    Product
    EL CHILAR CAMARON NATURAL, NATURAL SHRIMP, NET WT. 2 Oz. (57g) (in paper cartons) (12 packages per case of 2 oz each), DIST. BY: EL CHILAR., INGREDIENTS: PRECOOKED SHRIMP AND SALT, UPC: 874250003445.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0411-2024·2023-11-22

    Shrimp product recall due to undeclared Red #40 food coloring

    ORALE! CAMARON NATURAL shrimp in 2 oz. packages (Lot F-219) is recalled due to undeclared Red #40 food coloring. Approximately 7,584 units were distributed domestically.

    Product
    ORALE! CAMARON NATURAL, NATURAL SHRIMP, NET WT. 2 OZ. 57 g (in paper cartons) (12 packages per case of 2 oz each), PACKED & DISTRIBUTED BY: LISY CORP., INGREDIENTS: Precooked Shrimp and Salt., UPC: 096786203209.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0184-2024·2023-11-15

    Alaris PCA Module 8120 infusion pump recalled for unvalidated syringes

    CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.

    Product
    BD Alaris PCU REF 8015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recalled for Expiration Date Labeling Error

    Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2024·2023-11-15

    Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide