The Recall Desk

Hazard

Labeling Discrepancy recalls

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

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2026-07-22

Of the 13 labeling discrepancy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labeling discrepancy 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.

1–13 of 13

  • LowFDA (Devices)·Z-2740-2026·2026-07-22

    Rio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall

    3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).

    Product
    Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0905-2026·2025-12-17

    Short ureteral stent kits recalled over a size labeling discrepancy

    C.R. Bard is recalling 116 Bard InLay Optima Ureteral Stent Kits, 6 Fr x 14 cm, because the actual stent size may not match the product label.

    Product
    Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2026·2025-12-17

    Ureteral stent kits recalled because the stent size may not match the label

    C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 6 Fr x 30 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0908-2026·2025-12-17

    Ureteral stent kits, 8 French, recalled over a size labeling discrepancy

    C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 8 Fr x 26 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2026·2025-12-17

    Ureteral stent kits, 4.7 French, recalled over a size labeling discrepancy

    C.R. Bard is recalling 4,350 BD InLay Optima Ureteral Stent Kits, 4.7 Fr x 26 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2025·2024-11-13

    Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy

    Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.

    Product
    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2358-2024·2024-07-24

    Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error

    Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.

    Product
    Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2024·2024-07-24

    Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy

    Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.

    Product
    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2024·2024-02-07

    Medical sterilization chemical integrators recalled due to labeling discrepancy

    TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.

    Product
    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2023·2023-02-01

    Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device

    SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.

    Product
    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2023·2023-02-01

    AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy

    SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.

    Product
    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2021·2021-09-29

    Sight OLO-E1/U1 Reference Range Labeling Discrepancy in Software

    The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.

    Product
    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2021·2021-08-18

    Exactech hip prosthesis femoral head labeling and marking discrepancy

    Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.

    Product
    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide