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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

76–100 of 581

  • CriticalFDA (Devices)·Z-0427-2026·2025-11-12

    Insulin pumps recalled over false vibration motor failure stopping delivery

    Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.

    Product
    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
    Category
    Medical Device
    Distribution
    53 states
  • CriticalFDA (Devices)·Z-0161-2026·2025-11-05

    Neuro operating suites recalled over ice blockage in magnet venting paths

    IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0188-2026·2025-11-05

    Distal access catheters recalled after coating material lifting inside the lumen

    Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.

    Product
    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-0162-2026·2025-11-05

    MRI operating suites with Skyra magnet recalled over venting system blockage

    IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0164-2026·2025-11-05

    InVision operating suite recalled over ice blockage in magnet venting paths

    IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.

    Product
    IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0318-2026·2025-11-05

    Glucose monitoring app recalled because it can terminate and miss alerts

    Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.

    Product
    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexc
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0163-2026·2025-11-05

    MRI operating suites recalled over ice blockage in the magnet venting system

    IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.

    Product
    IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0154-2026·2025-10-29

    IV burette sets recalled over missing internal shutoff valve component

    ICU Medical is recalling 23,203 IV administration sets because the burette component is missing an internal shutoff valve intended to stop fluid flow.

    Product
    IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0070-2026·2025-10-29

    Hemodialysis bloodline sets recalled over micro air bubbles from damaged connectors

    B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.

    Product
    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0136-2026·2025-10-29

    Impella controllers recalled over purge pressure issues from retainer failures

    Abiomed is recalling Automated Impella Controllers over the potential for purge pressure issues caused by purge retainer failures, covering 9,177 distributed units.

    Product
    Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0102-2026·2025-10-22

    VALITUDE MRI resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 28,911 VALITUDE CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U128, VALITUDE CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0089-2026·2025-10-22

    PROPONENT dual chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 106,536 PROPONENT DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L211 PROPONENT DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0088-2026·2025-10-22

    PROPONENT single chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 41,009 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L210 PROPONENT SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0067-2026·2025-10-22

    BF-XT40 bronchofiberscopes recalled for updated therapy equipment use instructions

    Olympus is recalling OES Bronchofiberscope BF Type XT40 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0109-2026·2025-10-22

    UniD curve ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 407 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve D configuration after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0098-2026·2025-10-22

    ALTRUA 2 single chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 4,841 ALTRUA 2 SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S701 ALTRUA 2 SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0082-2026·2025-10-22

    ACCOLADE dual chamber MRI pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 90,931 ACCOLADE DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR SL MRI (Model L311)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0095-2026·2025-10-22

    Pacemakers recalled for software update preventing Safety Mode from battery impedance

    Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L111, ESSENTIO DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0051-2026·2025-10-22

    BF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0111-2026·2025-10-22

    Curve D-F ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0112-2026·2025-10-22

    Curve F-J ablation catheters recalled after tip detachment during unpacking

    Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0110-2026·2025-10-22

    Curve D-D ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 3,404 TactiFlex Sensor Enabled Ablation Catheters in the D-D curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0097-2026·2025-10-22

    ESSENTIO extended life MRI pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 190,088 ESSENTIO DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L131, ESSENTIO DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states