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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201–225 of 581

  • CriticalFDA (Devices)·Z-2459-2025·2025-09-10

    IDM-ARLITE-R wheelchair controls recalled over unintended movement on power-up

    IDM-ARLITE-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 25 units are affected.

    Product
    IDM-ARLITE-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2333-2025·2025-09-10

    Syringe pumps recalled over false motor movement system error messages

    Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.

    Product
    Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2334-2025·2025-09-10

    Novum IQ syringe pumps recalled over software anomalies affecting the run screen

    Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40700BAX, over software anomalies that may cause a blank Run screen or a false motor movement system error. 22,703 units are affected.

    Product
    Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2432-2025·2025-09-10

    TruSeal DBL access systems recalled over air embolism risk without ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2431-2025·2025-09-10

    WATCHMAN TruSeal access systems recalled over air embolism during transseptal access

    Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2460-2025·2025-09-03

    Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots

    Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.

    Product
    Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2328-2025·2025-08-27

    Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation

    Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.

    Product
    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2325-2025·2025-08-27

    ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI

    ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.

    Product
    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2327-2025·2025-08-27

    RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification

    RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.

    Product
    RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2326-2025·2025-08-27

    ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification

    ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.

    Product
    ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2173-2025·2025-08-20

    Infusion pumps recalled over underinfusion when flow rate more than doubles

    Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.

    Product
    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2273-2025·2025-08-20

    Carotid stent delivery systems recalled over resistance during withdrawal after deployment

    Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.

    Product
    Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2290-2025·2025-08-20

    HeartMate mobile power unit cords recalled over locking feature that may disconnect

    Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2181-2025·2025-08-20

    Manual resuscitators recalled because blocked manometer port may disable pressure gauge

    Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.

    Product
    Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1946-2025·2025-06-25

    Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

    Product
    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1945-2025·2025-06-25

    Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.

    Product
    Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1944-2025·2025-06-25

    Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error

    Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.

    Product
    Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1814-2025·2025-06-11

    Adult Manual Resuscitator with Medium Adult Mask recalled nationwide

    SunMed Holdings is recalling 11,358 Adult Manual Resuscitators because the filter may be incorrectly attached to the patient port instead of the exhalation port, risking interruption or delay in patient resuscitation that could cause serious harm or death.

    Product
    Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1746-2025·2025-05-28

    Endopath Echelon Vascular White Reload surgical stapler device lockout

    Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.

    Product
    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1668-2025·2025-05-14

    CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall

    Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.

    Product
    CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1662-2025·2025-05-14

    CADD Solis HSPCA Pump wireless connection alarm interruption recall

    Smiths Medical is recalling CADD Solis HSPCA Pumps with wireless connection modules that may experience intermittent connection alarms, interrupting active infusions and risking serious patient injury or death.

    Product
    CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1667-2025·2025-05-14

    CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction

    Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, risking serious patient injury or death.

    Product
    CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1533-2025·2025-04-23

    AutoPulse NXT Resuscitation System may fail to provide chest compressions

    ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.

    Product
    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, bat
    Category
    Medical Device
    Distribution
    19 states