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

8876–8900 of 39932

ModerateFDA (Devices)·Z-0212-2024·2023-11-08
Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk
Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.
Product
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0197-2024·2023-11-08
Quest Medical Recalls Q2 Multiport Intravenous Extension Sets
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
Product
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0217-2024·2023-11-08
DBS Lead Device Recall: Use By Date Label Discrepancy
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0204-2024·2023-11-08
Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
Product
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-0139-2024·2023-11-01
Centricity PACS-IW Medical Imaging System Mixed Patient Data
Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.
Product
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0051-2024·2023-11-01
PrestiBio Breast Milk Alcohol Test Strips Recalled for Lack of Marketing Authorization
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Product
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0045-2024·2023-11-01
UTI Test Strips Recalled for Lack of Quality Documentation and Compliance Verification
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
Product
HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0156-2024·2023-11-01
Omega Medical Imaging Monitor Suspension Actuator Separation Risk
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
Product
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0052-2024·2023-11-01
Diagnostic test products recalled by Universal Meditech for missing FDA clearance
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.
Product
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0174-2024·2023-11-01
Robotics Pack Sterilization Error Affects IV Catheter and Adhesive Components
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
Product
Robotics Pack SAH, REF SAR530M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2024·2023-11-01
Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery
The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.
Product
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2024·2023-11-01
Preat Neodent Healing Abutment Recalled Due to Dimensional Defect
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Product
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0064-2024·2023-11-01
FDA Recalls Pregnancy Test Cassettes Due to Unverified Manufacturing
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
Product
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0182-2024·2023-11-01
Cath Cardiac Pack sterilization failure may cause loss of functionality
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
Product
Cath Cardiac Pack, REF IHCC03V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0060-2024·2023-11-01
Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
Product
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0165-2024·2023-11-01
Grafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Product
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states

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8876–8900 of 39932