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.

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.

1226–1250 of 1428

  • HighFDA (Devices)·Z-2136-2025·2025-07-30

    Endosee system convenience trays label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.

    Product
    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2025·2025-07-30

    Discovery MR750w gradient coils can produce acoustic noise above the limit

    GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    Discovery MR750w 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0308-2025·2025-07-30

    Turkeyfoot Creek Creamery Avalanche ice cream has undeclared soy and wheat

    Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy and wheat. All expiration dates are affected.

    Product
    Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow irrigator with tip may leak solution into handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA kits give falsely increased results from a bovine albumin lot

    Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.

    Product
    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2135-2025·2025-07-30

    HSG procedure trays label non-sterile iodine pouches as sterile

    HSG Procedure Trays are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 171 units are affected.

    Product
    HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0535-2025·2025-07-30

    Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing

    Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.

    Product
    Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    SmartSync Patient Connector limited the window to abort high voltage therapy

    The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0541-2025·2025-07-30

    Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint

    Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0319-2025·2025-07-30

    Artisan style half loaves recalled over undeclared hazelnut from mispackaging

    Artisan Style 1/2 Loaf white bread is being recalled because product containing hazelnuts was put in bags whose allergen statement does not include hazelnuts. 883 loaves are affected.

    Product
    Artisan Style 1/2 Loaf, Net wt. 12 oz (340g) 024126018152 1/2 Loaf of white bread with white flour topping and two splits on top 7/13/2025 - Best By Flexible plastic bag
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2166-2025·2025-07-30

    Biofinity Toric Multifocal contact lens blisters may have a leaking seal

    Biofinity Toric Multifocal Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 827 units are affected.

    Product
    Biofinity Toric Multifocal Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow suction irrigator may leak solution into the handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2025·2025-07-30

    EMPOWR dual mobility OD42 bearings were packaged with the wrong implant

    EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.

    Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femora
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2134-2025·2025-07-30

    Azurion 7 M20 C-arm gearbox mounting bolts may become loose

    The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.

    Product
    Azurion 7 M20. Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0325-2025·2025-07-30

    Ritz cracker sandwich variety packs recalled over undeclared peanut from mispackaging

    Ritz Cracker Sandwiches 20 count variety packs are being recalled because of undeclared peanut allergens due to mispackaging. 13,872 cases are affected.

    Product
    Ritz Cracker Sandwiches, Variety 20 count variety Pack, (20- Packs of 10 Cheese 1.35 oz Packs and 10 Peanut Butter 1.38 oz Packs) Net Wt. 27.3 oz (20-1.38 oz packet of cracker sandwiches inside cartons of varying sizes). 20-27.3 OZ (Case: 6 - 27.3 Oz Cartons in master carton. UP
    Category
    Food
    Distribution
    49 states
  • HighFDA (Devices)·Z-2162-2025·2025-07-30

    BD COR system software issue could produce possible false negative results

    BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.

    Product
    BD COR System Software. Model Number: 444829.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2025·2025-07-30

    Nellcor bedside SpO2 monitor alarms may not be heard or recognized

    The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.

    Product
    Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2025·2025-07-30

    Endosee convenience kits label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.

    Product
    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2025·2025-07-30

    Natus brain monitor breakout box shows right side impedance under left

    The Natus Brain Monitor Breakout Box is being recalled after two complaints that the left side labeling showed impedance for the right side. 27 units are affected.

    Product
    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2131-2025·2025-07-30

    SIGNA Architect AIR gradient coils can produce acoustic noise above limit

    GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    SIGNA Architect AIR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2025·2025-07-30

    Biofinity XR Toric contact lens blisters may have a leaking seal

    Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.

    Product
    Biofinity XR Toric Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2025·2025-07-30

    SIGNA Architect gradient coils can produce acoustic noise above the limit

    GE HealthCare SIGNA Architect MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    SIGNA Architect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2025·2025-07-30

    CareLink SmartSync limited the window to abort a high voltage therapy

    Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0309-2025·2025-07-30

    Turkeyfoot Creek Creamery chocolate peanut butter ice cream has undeclared soy

    Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.

    Product
    Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
    Category
    Food
    Distribution
    3 states