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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4401–4425 of 39824

  • HighFDA (Devices)·Z-1258-2025·2025-03-12

    MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Travel

    Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 620G (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2025·2025-03-12

    AURORA Surgiscope System Obturator May Break or Separate

    Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.

    Product
    AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2025·2025-03-12

    CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction

    Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.

    Product
    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2025·2025-03-12

    MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight

    MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.

    Product
    MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2025·2025-03-12

    Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall

    Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.

    Product
    Philips IntelliSpace Cardiovascular software, Model 830089.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2025·2025-03-12

    Vios bedside monitor batteries may deplete during storage

    Murata Vios bedside monitors may experience battery depletion if stored without power, causing tablet connectivity issues. Affected units should be kept plugged in while in storage.

    Product
    Vios Monitoring System Bedside Monitor Model BSM2050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1272-2025·2025-03-12

    Dental abutment implants recalled for incorrect patient chart stickers

    Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.

    Product
    ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2025·2025-03-12

    Dental Abutments Recalled for Incorrect Version Identification Stickers

    Hiossen Inc. is recalling ET Rigid Abutments due to incorrect patient chart stickers that misidentify product versions. The stickers may label Mini abutments as Regular or identify other abutment models incorrectly, risking use of the wrong component.

    Product
    ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2025·2025-03-12

    BD BBL TB Stain Kit Expiration Date Labeling Discrepancy

    BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.

    Product
    BD BBL TB Stain Kit K, Catalog (REF): 212522
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1274-2025·2025-03-12

    Hiossen Dental Abutments Misidentified on Patient Chart Stickers

    Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.

    Product
    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2025·2025-03-12

    Dental implant abutments recalled for incorrect packaging labels

    Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.

    Product
    ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2025·2025-03-12

    ET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers

    Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.

    Product
    ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1251-2025·2025-03-12

    Infiltration Cannula Recalled Due to Incorrect Water Jet Pattern

    HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the water jet may emerge as a spot jet rather than the specified fan-shaped spray pattern, affecting device functionality.

    Product
    human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2025·2025-03-12

    Lumenis Pulse 120H Laser System Charger May Prevent Device Startup

    Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.

    Product
    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1196-2025·2025-03-05

    Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts

    Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.

    Product
    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1234-2025·2025-03-05

    Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect

    Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.

    Product
    Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2025·2025-03-05

    Orthopedic Plate Locking Screw May Pass Through Hole During Surgery

    Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2025·2025-03-05

    Clinical Chemistry Analyzer Fails to Track Assay Expiration Dates After Software Update

    A software issue in the DxC 500 AU analyzer prevents correct tracking of assay expiration dates after software upgrades. Expired assays may be used, potentially producing inaccurate patient test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1231-2025·2025-03-05

    Infusion Pump Manual Instructs Users to Leave Safety Clamp Open

    BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.

    Product
    BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1211-2025·2025-03-05

    Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2025·2025-03-05

    Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2025·2025-03-05

    Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect

    Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.

    Product
    Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2025·2025-03-05

    FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that the locking screw can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2025·2025-03-05

    Anatomic lateral fibula plate locking screw failure during surgery

    Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2025·2025-03-05

    GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption

    GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.

    Product
    SIGNA MR380, NMRI system, Non-US Only
    Category
    Medical Device
    Distribution
    Distributed nationwide