The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

8226–8250 of 22104

  • HighFDA (Food)·F-0558-2025·2025-02-19

    Lemon Jelly Sticks recalled for undeclared Yellow #5 and Potassium Sorbate

    The Candy Basket Inc. recalls Lemon Jelly Sticks WHITE because the label fails to disclose Yellow #5 dye and Potassium Sorbate. Consumers with sensitivities to these additives may be at risk.

    Product
    Lemon Jelly Sticks WHITE, item number CB750-W, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declar
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1121-2025·2025-02-19

    LVIS Intraluminal Support Device May Fail to Deploy Properly

    MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.

    Product
    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0541-2025·2025-02-19

    Riverside Cookies & Creme Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Cookies & Creme Granola Bars nationwide due to possible metal contamination. Consumers should not consume the affected products.

    Product
    1. Cookies & Creme Granola Bars 30.6oz (36 bars) 2. Cookies & Creme Granola Bars 5.1oz (6 bars) 3. Cookies & Creme Granola Bars 0.85 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2025·2025-02-19

    Cardiac Diagnostic Implant Recalled for Premature Device Failure

    Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.

    Product
    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2025·2025-02-19

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2025·2025-02-19

    Spore Test Monitoring System Printing Error May Cause Result Misdirection

    HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.

    Product
    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Food)·F-0563-2025·2025-02-19

    Cheese powder ingredient blend recalled for plastic thread contamination

    Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.

    Product
    5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Phosphate, Salt], Rice Starch, Sugar, Salt, Encapsulated Baking Soda (Sodium Bicar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0546-2025·2025-02-19

    Chocolate Drizzled Vanilla Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Vanilla Granola Bars nationwide due to potential metal piece contamination. Affected products should not be consumed.

    Product
    1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Vanilla Granola Bars 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2025·2025-02-19

    Medical laser device recalled for inadequate safety operating instructions

    Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.

    Product
    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2025·2025-02-19

    Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures

    The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0538-2025·2025-02-19

    Chocolate Banana Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Banana Granola Bars sold nationwide due to potential metal contamination. Consumers should not eat affected products and should consult a healthcare provider if consumed.

    Product
    1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2025·2025-02-19

    Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk

    Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.

    Product
    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0542-2025·2025-02-19

    Halloween Chocolate Chip Granola Mini Bars recalled for possible metal contamination

    Riverside Natural Foods is recalling Halloween Chocolate Chip Granola Mini Bars distributed nationwide due to possible metal pieces. Consumers should not eat these products.

    Product
    1. Halloween Chocolate Chip Granola Mini Bars 12.6oz (30 bars) 2. Halloween Chocolate Chip Granola Mini Bars 0.42oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1166-2025·2025-02-19

    Novation XLE hip implant components recalled for missing barrier layer

    Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.

    Product
    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Food)·F-0547-2025·2025-02-19

    Made Good Variety Pack recalled for potential metal contamination nationwide

    Riverside Natural Foods is recalling Made Good Variety Pack products nationwide due to potential metal contamination. Consumers should not consume the products and return them to retailers.

    Product
    1. Made Good Variety Pack 37ct 2.MadeGood Variety Pack 7ct
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0544-2025·2025-02-19

    Riverside Chocolate Drizzled Cookie Crumble Granola Bars Recalled for Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Cookie Crumble Granola Bars distributed nationwide due to potential metal contamination. Approximately 2.4 million cases are affected.

    Product
    1. Chocolate Drizzled Cookie Crumble Granola Bars 4.2oz (5 bars) 2. Chocolate Drizzled Cookie Crumble Granola Bars 25.5oz (30 bars) 3. Chocolate Drizzled Cookie Crumble Granola Bars 0.85oz 4. Chocolate Drizzled Granola Bars Variety Pack 25.5oz (30 bars)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2025·2025-02-19

    Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings

    Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.

    Product
    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25132·2025-02-13

    Portable Sleep Lamps Recalled Due to Lithium-Ion Battery Fire Hazard

    BlockBlueLight Multi-Mode Sleep Lamps are recalled because the lithium-ion battery can overheat while charging, creating fire and burn hazards. No injuries have been reported.

    Product
    Multi-Mode Sleep Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25131·2025-02-13

    SHEIN children's pajama sets recalled for flammability violation

    SHEIN Distribution Corporation recalls about 17,300 children's pajama sets sold on SHEIN.com between August 2023 and November 2024 for violating federal flammability standards for children's sleepwear, which poses a burn injury risk.

    Product
    SHEIN EVRYDAY Kids' Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25133·2025-02-13

    Spritz Resin Hanukkah Dino Menorahs Recalled Due to Fire Hazard

    About 4,400 Spritz Resin Hanukkah Dino Menorahs are recalled due to fire hazard. Target received 58 reports of the resin menorahs catching fire, scorching, charring, or melting when holding lit candles. No injuries reported. Return for full refund.

    Product
    Spritz Taper Resin Hanukkah Dino Menorahs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25135·2025-02-13

    AFTCO Youth Solitude Jackets Recalled for Strangulation Hazard

    AFTCO is recalling about 820 Youth Solitude Jackets due to a strangulation hazard from the retractable drawstring in the hood. The drawstring can get caught on objects, posing a risk of serious injury or death to children.

    Product
    Youth Solitude Jackets
    Category
    Consumer Product
    Distribution
    Distributed nationwide