The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) 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 mis 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.

3401–3425 of 9607

  • ModerateFDA (Devices)·Z-2641-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free that may contain small amounts of the chemical.

    Product
    88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2611-2018·2018-08-15

    ICU Medical Blood Set Recall for Incorrect DEHP Labeling

    ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2622-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2634-2018·2018-08-15

    ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2627-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.

    Product
    88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for need
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2643-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2607-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2615-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2626-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2018·2018-08-15

    INOmeters for INOflo Cylinders Recalled Due to Incorrect Expiration Date Programming

    INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.

    Product
    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2606-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2637-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2658-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

    ICU Medical is recalling specific blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2617-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2610-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood set accessories because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2650-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2625-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2628-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as DEHP-free but may contain small amounts of the chemical.

    Product
    121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2640-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they are labeled as not containing DEHP, even though they may contain small amounts of the chemical.

    Product
    112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2649-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2018·2018-08-15

    ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.

    Product
    125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2631-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they are labeled as not containing DEHP, but may contain small amounts of the chemical.

    Product
    140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
    Category
    Medical Device
    Distribution
    Distributed nationwide