The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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4676–4700 of 13449

  • 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-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-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 (Devices)·Z-0192-2025·2024-10-30

    Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction

    The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of monitoring, or inability to zero the device.

    Product
    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
    Category
    Medical Device
    Distribution
    0 states
  • 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-0013-2025·2024-10-30

    CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects

    Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.

    Product
    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0146-2025·2024-10-30

    Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue

    Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.

    Product
    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
    Category
    Medical Device
    Distribution
    0 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-0214-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk

    Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.

    Product
    Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0176-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2025·2024-10-30

    Medline catheter procedure kits recalled for potential sterility compromise

    Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2025·2024-10-30

    TranStar Disposable Pressure Transducer Kit recalled for manufacturing defect

    Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.

    Product
    medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0170-2025·2024-10-30

    Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise

    Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.

    Product
    Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk

    Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLO
    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-0018-2025·2024-10-30

    ENT Medication Reservoirs Recalled for Weakened Weld Joint

    Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.

    Product
    ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0015-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for weakened weld joint

    Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0156-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
    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-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • 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-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-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-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