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

3826–3850 of 39987

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-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-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-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-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-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-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-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-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
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-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-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-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-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
ModerateFDA (Devices)·Z-1861-2025·2025-06-04
Straumann Plus Initial Drill missing laser engraving marking
Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.
Product
Plus Initial Drill, Article Number: 103.170;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1842-2025·2025-06-04
Abbott Diagnostics ARCH AUSAB Anti-HBS Reagent Recall
Abbott Diagnostics ARCH AUSAB Anti-HBS reagent units may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms, potentially leading to incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1856-2025·2025-06-04
Glidewell HT Implant Twist Drill recalled due to packaging mix-up
Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.
Product
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1851-2025·2025-06-04
Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall
Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1876-2025·2025-06-04
VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.
Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1883-2025·2025-06-04
Ethos Collar Stem components recalled for potential Tyvek seal breach
Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.
Product
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1825-2025·2025-06-04
Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall
Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1859-2025·2025-06-04
Ultrasonic Cleaning Systems Triton 36 and 72 recalled
Ultra Clean Systems, Inc. is recalling Ultrasonic Cleaning Systems Triton 36 and Triton 72 models due to carbon filter sensors breaking down from electrochemical degradation. The defect was identified during routine preventative maintenance checks.
Product
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Category
Medical Device
Distribution
Distributed nationwide

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3826–3850 of 39987