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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

226–250 of 582

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-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-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-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-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-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
CriticalFDA (Devices)·Z-1289-2025·2025-03-19
Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
Product
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1257-2025·2025-03-12
Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Product
Paradigm insulin pump, REF: MMT-754
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1244-2025·2025-03-12
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1070-2025·2025-02-26
Vascular Tack Endovascular System recalled for deployment and migration risks
Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.
Product
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1144-2025·2025-02-26
Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Product
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1152-2025·2025-02-26
Philips Allura Xper Patient Table Mattress Defect Fall Risk
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
Product
Allura Xper FD10C; Catalog number: 722001
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0825-2025·2025-01-22
ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0884-2025·2025-01-22
Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Product
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0887-2025·2025-01-22
Life2000 Ventilation System battery charger defect causes device inoperability
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0830-2025·2025-01-22
Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Product
Impella RP Flex with SmartAssist; Product Number: 1000323;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0382-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0303-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Product
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0304-2025·2024-11-20
Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0310-2025·2024-11-20
Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0005-2025·2024-10-16
Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Product
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-3084-2024·2024-09-25
Baxter pharmaceutical compounding inlets recalled for particulate matter contamination
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2973-2024·2024-09-18
Smiths Medical Pneupac paraPAC plus 300 Ventilator Kit Recalled for Knob Movement
Smiths Medical ASD Inc. is recalling Pneupac paraPAC plus 300 ventilator kits because the tidal volume knob may move from its original setting.
Product
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
Category
Medical Device
Distribution
0 states

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