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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4051–4075 of 27375

  • 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-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-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-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-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-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-0219-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error

    Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0012-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0215-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Hazard

    Baxter Healthcare recalled 24 units of its TruSystem 7000 operating table worldwide due to battery and connector electrical short-circuits and smoke emission.

    Product
    Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0201-2025·2024-10-30

    Blood Sample Pressure Kit Recalled for Monitoring Defects

    Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.

    Product
    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
    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-0014-2025·2024-10-30

    CADD Medication Cassette Reservoir weld defect poses leakage risk

    Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.

    Product
    CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
    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 (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-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-0180-2025·2024-10-30

    Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging

    Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.

    Product
    Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
    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-0211-2025·2024-10-30

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

    Baxter Healthcare Corporation is recalling the TruSystem 7000 Operating Table due to battery and connector short-circuits that can emit smoke, creating fire and electrical hazards during surgery.

    Product
    Baxter Operating Table TruSystem 7000, Product code REF 1841046
    Category
    Medical Device
    Distribution
    0 states
  • 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-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 (Devices)·Z-0198-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 900 units of medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
    Category
    Medical Device
    Distribution
    0 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