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.

6776–6800 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-0169-2025·2024-10-30

    Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk

    Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0153-2025·2024-10-30

    Medline Procedure Kits Recalled for Non-Sterile Product Risk

    Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0060-2025·2024-10-30

    Farmers Juice Focus Greens Recalled Due to Incomplete Pasteurization

    Youngstown Grape Distributors is recalling Farmers Juice Focus Greens due to incomplete pasteurization, which may allow bacterial growth. Approximately 7,909 bottles with lot H240906-G are affected.

    Product
    Farmers Juice Focus Greens packaged in a 12 fl. oz. bottle; Ingredients: Cucumber, Celery, Fennel, Romaine Lettuce, Lemon, Mint, Green Cabbage, Ginger, Turmeric, Basil, & Matcha. UPC: 00860006798048
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0079-2025·2024-10-30

    Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet

    Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.

    Product
    Amingo. OUS only.
    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-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-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-0202-2025·2024-10-30

    medex TranStar Pressure Transducer Stopcock Recalled for Manufacturing Defect

    Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.

    Product
    medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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 (Devices)·Z-0155-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product

    Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2025·2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2025·2024-10-30

    Internal Defibrillation Paddles Recalled for Cracks and Separation

    Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.

    Product
    STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2025·2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2025·2024-10-30

    Smiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty

    Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.

    Product
    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0172-2025·2024-10-30

    Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised

    Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.

    Product
    Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2025·2024-10-30

    Medline medical procedure kits recalled for potential sterility breach

    Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2025·2024-10-30

    Shimadzu Trinias Unity Catheterization Table Movement Control Defect

    Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.

    Product
    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2025·2024-10-30

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

    Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0213-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 recalled for electrical hazard

    Baxter is recalling 1,077 TruSystem 7000 operating tables worldwide due to electrical short-circuits and smoke emissions in battery connectors reported by customers.

    Product
    Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0150-2025·2024-10-30

    Medline Centurion Medical Procedure Kits Recalled for Sterility Risk

    Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.

    Product
    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide