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

626–650 of 1396

SevereFDA (Devices)·Z-0170-2024·2023-11-08
Senhance Robotic Surgical System uncontrolled arm motion malfunction
Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.
Product
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system
Category
Medical Device
Distribution
5 states
CriticalFDA (Devices)·Z-0149-2024·2023-11-01
Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
Product
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0123-2024·2023-11-01
B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
Product
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0124-2024·2023-11-01
Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
Product
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0147-2024·2023-11-01
Monoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.
Product
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0146-2024·2023-11-01
Monoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility
Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.
Product
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0111-2024·2023-11-01
ResMed Astral ventilators recalled for power loss and failed alarms
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
Product
Astral 100 and Astral 150 ventilators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0148-2024·2023-11-01
Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.
Product
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0150-2024·2023-11-01
Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.
Product
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0145-2024·2023-11-01
Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
Product
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0075-2024·2023-10-25
Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
Product
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0094-2024·2023-10-25
Sapphire Infusion Pumps recalled for software air-detection failure
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
Product
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0028-2024·2023-10-18
FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
Product
2008T Hemodialysis SYS, with CDX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0033-2024·2023-10-18
Hemodialysis machines recalled for potential PCBA leaching from tubing
Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.
Product
2008T HD SYS. CDX W/BIBAG BLUESTAR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0029-2024·2023-10-18
Hemodialysis machines recalled for potential printed circuit board contamination
Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.
Product
2008T Hemodialysis System without CDX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2024·2023-10-18
10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage
Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.
Product
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0030-2024·2023-10-18
2008T Hemodialysis System recalled for potential PCBA leaching from tubing
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.
Product
2008T Hemodialysis System w/Bibag
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0034-2024·2023-10-18
Hemodialysis machines recalled due to potential circuit board material leaching
Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.
Product
2008T HD SYS. W/O CDX BLUESTAR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0032-2024·2023-10-18
Hemodialysis Machines Recalled Due to Potential PCBA Leaching
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.
Product
2008T HD SYS. CDX BLUESTAR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0005-2024·2023-10-18
FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material
Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.
Product
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0031-2024·2023-10-18
Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching
Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.
Product
2008T GEN 2 Bibag without CDX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0007-2024·2023-10-18
Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk
Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.
Product
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0035-2024·2023-10-18
Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.
Product
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0003-2024·2023-10-11
Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling
Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.
Product
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0002-2024·2023-10-11
Arrow ErgoPack central venous catheter recalled for incorrect labeling
ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.
Product
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Category
Medical Device
Distribution
0 states

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