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.

526–550 of 1428

  • ModerateFDA (Devices)·Z-1836-2026·2026-04-29

    Medline left heart kits recalled after 510(k) clearances were rescinded

    Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.

    Product
    Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0670-2026·2026-04-29

    Bombay Kitchen Punjabi Mix contains undeclared FD&C colors

    Bombay Kitchen brand Punjabi Mix is being recalled because the product contains undeclared colors, FD&C Yellow #6 and FD&C Red #40. 69 cases are affected.

    Product
    Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Chana Dal (Split Bengal Gram), Brown Lentils (Masoor), Chickpeas, Rice Flakes, Puffed Rice, Spices, Sugar, Peanuts, Raisins, Yogurt (pasteurized Grade A M
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1817-2026·2026-04-22

    Cytal Wound Matrix recalled over out-of-specification endotoxin test results

    Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2026·2026-04-22

    Yeastone Broth recalled because it may report incorrect susceptibility results

    Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2026·2026-04-22

    Huons lidocaine 2% injection recalled over lack of sterility assurance

    Lidocaine HCl Injection, USP 2% in 5 mL single-dose vials manufactured by Huons is being recalled for lack of assurance of sterility. All lots within expiry are affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2026·2026-04-22

    Cytal Wound Matrix 5x5 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2026·2026-04-22

    Instinct Plus endoscopic clipping devices may malfunction during use

    The Instinct Plus Endoscopic Clipping Device is being recalled after increased complaints indicating the device has the potential to malfunction. 713,702 units are affected.

    Product
    Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2026·2026-04-22

    Philips Spectral CT on Rails recalled over three software issues

    Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.

    Product
    Philips Spectral CT on Rails. Model Number: 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2026·2026-04-22

    Elegance anterior cervical plates recalled over burrs on finished product

    Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.

    Product
    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" So
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0665-2026·2026-04-22

    Booey's Dragon's Breath sauce omits fish and sesame from contains statement

    Booey's Dragon's Breath sauce is being recalled because the ingredients statement declares anchovy and sesame but the contains statement does not declare fish and sesame.

    Product
    Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Wat
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2026·2026-04-22

    Skin Script blemish spot treatment recalled for failing stability specifications

    Skin Script Blemish Spot Treatment containing 1% salicylic acid is being recalled after it failed stability specifications. The action covers 28,163 bottles.

    Product
    Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2026·2026-04-22

    Arjo Tenor patient lift actuators may lose the ability to hold load

    Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.

    Product
    Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2026·2026-04-22

    iLet Ace insulin pump lock screens can be bypassed by users

    iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.

    Product
    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2026·2026-04-22

    Philips AneurysmFlow MAFA ratio does not give reliable prognostic information

    Philips is recalling AneurysmFlow because the Mean Aneurysm Flow Amplitude ratio does not reliably predict aneurysm occlusion after flow diverter stent treatment, yet is relied on clinically.

    Product
    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2026·2026-04-22

    ARTIS Pheno 3D acquisitions may capture uneven patient image brightness

    ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.

    Product
    ARTIS Pheno VE30A and VE40A, Model 10849000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2026·2026-04-22

    Cytal Burn Matrix recalled over out-of-specification endotoxin test results

    Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.

    Product
    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2026·2026-04-22

    Bupivacaine spinal ampules recalled nationwide over lack of sterility assurance

    Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP ampules are being recalled for lack of assurance of sterility. The action covers 3,260,170 ampules.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2026·2026-04-22

    Centurion circumcision kits distributed without the required sterilization process

    Medline is recalling one lot of Centurion Circumcision Kits that was distributed without undergoing the required sterilization process and is therefore not sterile. 640 kits are affected.

    Product
    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0483-2026·2026-04-22

    IMS epinephrine injection vials recalled over lack of sterility assurance

    International Medication Systems is recalling one lot of Epinephrine Injection, USP, 1 mg/10 mL, citing lack of assurance of sterility. 81,520 units are affected.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2026·2026-04-22

    Spectra sodium chloride ampules recalled over lack of sterility assurance

    0.9% Sodium Chloride Injection, USP in 10 mL single dose ampules supplied for Spectra Medical Devices is being recalled for lack of assurance of sterility. 7,120,750 ampules are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0681-2026·2026-04-22

    Pure Palm Medjool dates packaging carries the wrong product label

    Pure Palm Medjool Dates are being recalled because coconut-covered date bites were packed in containers labelled for regular date bites. 50 cases are affected.

    Product
    Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
    Category
    Food
    Distribution
    5 states