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.

151–175 of 209

  • HighFDA (Devices)·Z-0017-2023·2022-10-19

    Hobbs Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling transbronchial aspiration needles with incorrect expiration dates on labels. The 18 affected units were distributed in the US, Canada, Austria, Belgium, Finland, and Norway from March 2018 to September 2020.

    Product
    Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2023·2022-10-19

    Hobbs Medical Polypectomy Snare Incorrect Expiration Date Label Recall

    Hobbs Medical polypectomy snares have incorrect expiration dates on labels that extend the device shelf life beyond safe limits. Affected products distributed from March 2018 to September 2020 may be used past their intended expiration.

    Product
    Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Recalled for Incorrect Expiration Date

    Hobbs Medical recalled Freeman Pancreatic Flexi-Stents due to incorrect expiration dates on device labels. The mislabeled dates extend shelf life, potentially allowing use of expired devices.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2023·2022-10-19

    Medical Device Retrieval Basket Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates on labels. The labeled shelf life extends beyond the actual safe duration for device use.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2022·2022-09-28

    BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates

    CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.

    Product
    BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1759-2022·2022-09-28

    BD MaxGuard Extension Set Recalled for Incorrect Expiration Year

    CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-1774-2022·2022-09-28

    Fungitell STAT IVD Assay affected by incorrect printed reconstitution instructions

    Associates of Cape Cod is recalling Fungitell STAT IVD Assay kits due to incorrect printed information on clamshells regarding reconstitution and pretreatment volumes. Users should verify procedures against official documentation before use.

    Product
    Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1703-2022·2022-09-14

    Select Bakery Peanut Butter Delight recalled for undeclared soy and Red #40

    Select Bakery Peanut Butter DELIGHT (3 oz packages) is recalled because it contains undeclared soy and Red #40. The product was distributed to Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Peanut Butter DELIGHT Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10028 5
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1569-2022·2022-08-31

    Anatomical Model Recalled for Wrong Product Shipped in Packaging

    Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.

    Product
    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2022·2022-07-20

    Aesculap Micro Needleholder Recalled for Incorrect Size Labeling

    Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.

    Product
    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1369-2022·2022-07-20

    Invacare Platinum 5NXG Oxygen Concentrator Recall Due to Missing Rx Only Label Statement

    Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.

    Product
    Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1261-2022·2022-06-22

    FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling

    Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.

    Product
    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1120-2022·2022-06-01

    Protekt Sharps Safety Knives with Incorrect Size Label

    International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.

    Product
    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle La
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1104-2022·2022-05-25

    HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish

    HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1103-2022·2022-05-25

    HeartWare HVAD System Controller Recalled for Translation Errors in Documentation

    Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1035-2022·2022-05-11

    Elegant Foods Fall Spice Macarons Recalled for Undeclared Food Coloring

    Elegant Foods is recalling Fall Spice Macarons because the packaging does not declare six artificial food colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, and Red #40.

    Product
    elegant foods Fall Spice Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1036-2022·2022-05-11

    Elegant Foods Lavender Macaron Recall for Undeclared Food Colors

    Elegant Foods is recalling Lavender Macarons (code 21264A) due to undeclared food colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, and Red #40. Affected cases were distributed in Wisconsin.

    Product
    elegant foods Lavender Macaron, Case of 100. 537 Atlas Ave, Madison, WI 53714.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0948-2022·2022-04-27

    Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling

    Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2022·2022-04-06

    Hip prosthetic femoral head component size and offset labeling mismatch

    Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.

    Product
    Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2022·2022-04-06

    Medtronic MiniMed insulin pumps may not deliver basal insulin without configuration

    Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.

    Product
    MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS O
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-0846-2022·2022-04-06

    BALLARD Multi-Access Port Catheter Distributed With Incorrect Expiration Dates

    Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.

    Product
    BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2022·2022-04-06

    BALLARD Seal Cassette Replacement catheters recalled for incorrect expiration date

    Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.

    Product
    BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2022·2022-03-30

    Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label

    Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.

    Product
    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
    Category
    Medical Device
    Distribution
    Distributed nationwide