The Recall Desk

Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,428
Critical
0
Severe
0
Most recent
2026-07-08

Of the 1,428 class ii 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 class ii 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.

1001–1025 of 1428

  • HighFDA (Devices)·Z-2294-2025·2025-08-20

    Custom tubing kits recalled because high pressure tubing may trap air

    Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0500-2025·2025-08-20

    Frozen oyster meat potentially contaminated with norovirus recalled in limited distribution

    Frozen Oyster Meat (IQF) is being recalled because the product is potentially contaminated with norovirus. 225 cartons are affected.

    Product
    Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expiration: 02/06/2027 UPC: 8809366955717
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0461-2025·2025-08-20

    Bubble gum paletas recalled because label lists cream without naming milk

    La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.

    Product
    La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0578-2025·2025-08-20

    Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level

    Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0463-2025·2025-08-20

    Coconut con crema 6-pack paletas recalled over undeclared milk in cream

    La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.

    Product
    La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2025·2025-08-20

    Kittner roll gauze with tail recalled over contamination and incorrect pack quantity

    Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0465-2025·2025-08-20

    La Michoacana variety paletas list cream without declaring milk as source

    La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.

    Product
    La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0467-2025·2025-08-20

    Rompope bolis 6-count packs recalled over cream ingredient missing milk source

    La Michoacana Rompope Bolis 6-Count 24 oz packs are recalled nationwide because the label lists cream but does not declare milk as its source. 11,274 units are affected.

    Product
    La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2025·2025-08-20

    SIGNA PET/MR AIR system recalled where caster lock maintenance may be missing

    GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2317-2025·2025-08-20

    SIGNA Hero Elite patient table caster lock checks may have been missed

    GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2313-2025·2025-08-20

    SIGNA Premier XT patient table caster lock checks may have been missed

    GE SIGNA Premier XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 2 units affected.

    Product
    GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2288-2025·2025-08-20

    Prosthesis heads carry inconsistent size terminology and color coding on labeling

    Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2292-2025·2025-08-20

    Bartels Legionella urinary antigen kits may contain particulate matter

    Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.

    Product
    Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2025·2025-08-20

    SIGNA Premier MAX patient table caster lock checks may have been missed

    GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2302-2025·2025-08-20

    Optima MR450w 1.5T MRI recalled where caster lock maintenance may be unperformed

    GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2306-2025·2025-08-20

    Discovery MR750 3.0T systems recalled over patient table caster lock maintenance gap

    GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2312-2025·2025-08-20

    SIGNA Architect AIR MRI recalled over unverified patient table caster lock maintenance

    GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2307-2025·2025-08-20

    Discovery MR750w patient table caster lock checks may have been missed

    GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.

    Product
    GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states