The Recall Desk

Hazard

Inadequate Labeling recalls

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

What the numbers show

Total
14
Critical
1
Severe
4
Most recent
2025-04-02

Of the 14 inadequate labeling recalls we have scored against our rubric, 1 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (29%) are Severe.

Which agencies issued them

About this hazard tag

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

1–14 of 14

  • SevereFDA (Devices)·Z-1396-2025·2025-04-02

    CVAC Aspiration System Requires Labeling Update for Pressure Risk

    The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.

    Product
    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2024·2024-09-11

    Impella CP Smart Assist Set Recalled for Device Interaction Labeling Update

    Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.

    Product
    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2024·2024-09-11

    Impella 5.5 Cardiac Pump Labeling Updated for Device Interaction Risk

    Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.

    Product
    Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0541-2024·2023-12-27

    AirFit F30 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.

    Product
    AirFit F30 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2024·2023-12-13

    Stay Safe Cap Labeling Recall for Additional Safety Warnings

    Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.

    Product
    Stay Safe Cap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2023·2023-03-22

    Hair Growth Laser Comb Recalled for Missing Safety Warnings and Labels

    OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.

    Product
    Recreo Hair Growth Laser Comb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1783-2022·2022-10-12

    Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings

    Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.

    Product
    Wisp and Wisp Youth Nasal Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2022·2021-10-13

    Medical cooler-heater device recalled for inadequate maintenance and inspection guidance

    CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2021·2021-10-06

    Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case

    Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements

    Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2369-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).

    Product
    Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2363-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates

    Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0923-2021·2021-08-25

    Lebenswert Folgemilch Stage 3 Organic Toddler Formula Recalled

    Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English as required by federal regulations.

    Product
    Lebenswert Folgemilch Stage 3 Organic Toddler Formula
    Category
    Food
    Distribution
    0 states