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

2601–2625 of 27375

SevereFDA (Devices)·Z-1818-2025·2025-06-04
ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem
Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2025·2025-06-04
Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2025·2025-06-04
Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
Product
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1872-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
Product
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2025·2025-06-04
Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1849-2025·2025-06-04
Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion
Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2025·2025-06-04
Abbott Diagnostics Architect Free T4 Calibrator Recall
Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2025·2025-06-04
Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires
Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.
Product
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2025·2025-06-04
ELEOS Male-Female Midsection 40MM Orthopedic Component Recall
Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2025·2025-06-04
Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue
The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2025·2025-06-04
NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.
Product
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2025·2025-06-04
Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2025·2025-06-04
Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2025·2025-06-04
Segmental Stem Components for ELEOS Limb Salvage System Recalled
Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.
Product
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1877-2025·2025-06-04
BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1860-2025·2025-06-04
DORO Easy-Connect Navigation Adaptor compatibility issue recall
Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.
Product
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2025·2025-06-04
Cholestech LDX Lipid Profile and Glucose Test Kits Recalled
McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2025·2025-06-04
GM Helix Acqua Implant dental implant size misidentification recall
Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.
Product
GM Helix Acqua Implant, Article Number: 140.985
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2025·2025-06-04
Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion
Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1823-2025·2025-06-04
Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall
The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Category
Medical Device
Distribution
2 states
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
SevereFDA (Devices)·Z-1755-2025·2025-05-28
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.
Product
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1756-2025·2025-05-28
Bard Blakemore Esophageal-Nasogastric Tube difficult balloon inflation
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.
Product
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Category
Medical Device
Distribution
52 states

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2601–2625 of 27375