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

4326–4350 of 39824

HighFDA (Devices)·Z-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2025·2025-03-26
Zebra Thermal Barcode Printer power supply units recalled due to fire hazard
Remel, Inc. is recalling approximately 41 Zebra Thermal Barcode Printer GX430t power supply units due to a potential fire hazard. The power supplies may overheat, creating a fire risk.
Product
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1342-2025·2025-03-26
Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
Product
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2025·2025-03-26
Medical Device Sterilization Assurance Recall: MAJOR DIEP Surgical Kits
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
Product
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2025·2025-03-26
Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2025·2025-03-26
Laceration Tray Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2025·2025-03-26
CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Product
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1372-2025·2025-03-26
Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier
37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1373-2025·2025-03-26
Hip Prosthetic Stem Recalled for Incorrect Product Code Label
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1371-2025·2025-03-26
Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
Product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1391-2025·2025-03-26
IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1374-2025·2025-03-26
Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling
Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2025·2025-03-26
Access 2 Immunoassay Analyzer motor alignment issue may delay results
Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.
Product
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1387-2025·2025-03-26
Beckman Coulter DxI 9000 Analyzer Communication Failure Recall
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Category
Medical Device
Distribution
Distributed nationwide
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
SevereFDA (Devices)·Z-1305-2025·2025-03-19
BD Care Coordination Engine Software May Send Outdated Programming Requests
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Product
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Category
Medical Device
Distribution
21 states
SevereFDA (Devices)·Z-1306-2025·2025-03-19
Aortic Root Cannula Recall for Loose Male Luer Component
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.
Product
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, m
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1304-2025·2025-03-19
BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue
BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.
Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1324-2025·2025-03-19
Philips Spectral CT on Rails software recall due to scanning and movement issues
Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1307-2025·2025-03-19
CardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
Product
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2025·2025-03-19
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2025·2025-03-19
GE Healthcare CT Scanner Systems Recalled Due to Coolant Leak Risk
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
Product
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1326-2025·2025-03-19
Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2025·2025-03-19
GE Revolution CT and Apex systems coolant fluid leak hazard
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
Product
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states

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