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.

6751–6775 of 52962

  • HighFDA (Devices)·Z-0216-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards

    Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.

    Product
    Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring

    Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.

    Product
    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0168-2025·2024-10-30

    Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product

    Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.

    Product
    Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk

    Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0058-2025·2024-10-30

    Juice Recall: Incomplete Pasteurization in Happy Moose Tropical Roots

    Happy Moose Juice Tropical Roots is recalled due to incomplete pasteurization of certain bottles. Consumers should not consume products with lot number H240903-E and enjoy-by date 12/02/2024.

    Product
    Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0133-2025·2024-10-30

    Medline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects

    Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.

    Product
    (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2025·2024-10-30

    CADD Medication Cassette Reservoir Recalled for Weld Defect Risk

    Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0010-2025·2024-10-30

    CADD Medication Cassette Reservoirs recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0200-2025·2024-10-30

    Medex TranStar Kids blood sample kit recalled for pressure monitoring failures

    Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.

    Product
    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0160-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk

    Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2025·2024-10-30

    Medtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer

    Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.

    Product
    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0136-2025·2024-10-30

    Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard

    B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.

    Product
    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0063-2025·2024-10-30

    SureLife Foods Paleo Bars recalled for undeclared gluten

    SureLife Foods Paleo Bars labeled as gluten-free contain gluten above 20 ppm according to consumer advocacy group testing. Approximately 48,384 units were distributed in California and Oregon.

    Product
    Principal Display: SureLife Foods PALEO BARS, Net Wt. 14 oz. (392 g.)- 14 ct. individually wrapped bars (28 g. each) Certified Gluten Free, Certified Paleo Loaed with: Almonds, Honey, Shredded Coconut, Pumpkin Seeds, Brazil Nuts, Chia Seeds & More! Back Display: Ingredients:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0137-2025·2024-10-30

    SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption

    Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.

    Product
    SynchroMed II Infusion Pump. Product Number: 8637-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy

    Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging defect

    Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error

    Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2025·2024-10-30

    Baxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk

    Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.

    Product
    Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0171-2025·2024-10-30

    Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk

    Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0061-2025·2024-10-30

    Farmers Juice Carrot Digest Recalled Due to Incomplete Pasteurization Risk

    Farmers Juice Carrot Digest is being recalled for incomplete pasteurization, which fails to eliminate harmful bacteria. About 2,521 bottles were distributed across multiple U.S. states.

    Product
    Farmers Juice Carrot Digest packaged in a 12 fl. oz. bottle; Ingredients: Orange, Lemon, Carrot, Ginger, Jicama UPC: 00860006798116
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0023-2025·2024-10-30

    Injectable Thiamine Drug Recalled for Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.

    Product
    Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2025·2024-10-30

    CADD Medication Cassette Reservoir Recall Due to Defective Weld Joint

    Smiths Medical is recalling CADD Medication Cassette Reservoirs with defective weld joints that may cause medication leakage. The issue affects 8,976 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0191-2025·2024-10-30

    Smiths Medical medex TranStar Pressure Monitoring Kits Recalled for Manufacturing Defect

    Smiths Medical is recalling 5,880 medex TranStar pressure monitoring kits worldwide due to a manufacturing defect that may cause inaccurate readings, monitoring interruption, or inability to zero the device.

    Product
    medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0223-2025·2024-10-30

    A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes

    Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.

    Product
    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2025·2024-10-30

    Centurion OB Tray medical kit recalled due to potential non-sterility

    Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.

    Product
    Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide