The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1551–1575 of 21588

  • ModerateFDA (Devices)·Z-2461-2025·2025-09-03

    Surgical driver systems recalled over out of the box driver wobble

    IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.

    Product
    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2416-2025·2025-09-03

    NovoTHOR light therapy devices recalled over welded nut that may shear

    NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2025·2025-09-03

    NovoTHOR XL devices recalled over failed welded nut detaching gas strut

    NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2025·2025-09-03

    Anti-Xa test kits recalled over potential contamination by fibrinogen reagents

    STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.

    Product
    STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0526-2025·2025-09-03

    Red bell pepper hummus recalled because label omits keep refrigerated instruction

    Gelson's Red Bell Pepper Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0523-2025·2025-09-03

    Tzatziki sauce recalled because label omits keep refrigerated storage instruction

    Gelson's Tzatziki, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt California-Made; NET WT. 8OZ (226g) UPC: 23631-10268
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2025·2025-09-03

    Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement

    Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.

    Product
    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0524-2025·2025-09-03

    Low sodium classic hummus recalled over missing keep refrigerated storage instruction

    Gelson's Low Sodium No Cholesterol Classic Hummus, 10 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10OZ (283g) UPC: 23631-10260
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0532-2025·2025-09-03

    Passionflower herb extract recalled over misbranding of the bulk ingredient

    Passionflower Herb Powdered Extract 4% in bulk packaging is recalled for misbranding of the ingredient. The recall covers 775 kg sent to a single consignee in North Carolina.

    Product
    Passionflower Herb Powdered Extract 4%, bulk packaging, individual large box, corrugated cardboard box with plastic liner .
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2421-2025·2025-09-03

    Dental implant locating kits recalled over thread defect limiting full engagement

    Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.

    Product
    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2025·2025-09-03

    Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles

    PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.

    Product
    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2418-2025·2025-09-03

    NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy

    A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2025·2025-09-03

    Medication dispensing stations recalled because antivirus software was not consistently installed

    BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.

    Product
    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2025·2025-09-03

    Dialysis control units recalled over false blood leak detection alarms

    PrisMax V3 Control Units are recalled because of unexpected blood leak alarms when no leak is present, or difficulty normalizing the blood leak detector. 2,449 units are affected.

    Product
    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2439-2025·2025-09-03

    Blood warmer units recalled because system may not detect inserted bag

    TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.

    Product
    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2419-2025·2025-09-03

    Light therapy devices recalled over welded nut that may shear off

    Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-08292025-01·2025-08-29

    Trader Joe's Frozen Pepperoni Pizza Imported Without Reinspection

    USDA FSIS issued a public health alert for Trader Joe's frozen pepperoni pizza imported from Italy without required reinspection. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert for a Frozen Pepperoni Pizza Product Imported Without the Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2337-2025·2025-08-27

    Strep A test kits recalled after shipment to unlicensed purchasing customers

    Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.

    Product
    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2025·2025-08-27

    Tavaborole topical solution recalled after discoloration found in one lot

    Tavaborole Topical Solution 5%, 10 mL bottles from lot T401968, distributed by Viona Pharmaceuticals, is recalled because of discoloration. 3,960 bottles are affected.

    Product
    TAVABOROLE — TAVABOROLE (TAVABOROLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2335-2025·2025-08-27

    Calcium test slides recalled after calibration failures delayed patient results

    VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.

    Product
    VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2345-2025·2025-08-27

    ELISA sample tip racks recalled over internal label misidentifying tip type

    Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.

    Product
    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
    Category
    Medical Device
    Distribution
    5 states