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

3801–3825 of 13543

HighFDA (Devices)·Z-1184-2025·2025-02-26
LIFEPAK 15 Monitor Software Error Disables Sensor Monitoring
Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.
Product
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2025·2025-02-26
Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning
RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1190-2025·2025-02-26
RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning
RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1178-2025·2025-02-26
AnchorFast Guard Select endotracheal tube fasteners recalled due to decreased skin barrier wear
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
Product
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2025·2025-02-26
RayStation radiation therapy software recall for density calculation inconsistency
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1171-2025·2025-02-26
Augustine HotDog return electrode connector cables electrode contact error recall
Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.
Product
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1203-2025·2025-02-26
Dexcom G6 glucose receiver may fail to deliver high or low alarms
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2025·2025-02-26
Endotracheal Tube Fastener Recalled for Potential Tube Migration Risk
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
Product
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1185-2025·2025-02-26
Radiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.
Product
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2025·2025-02-26
RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2025·2025-02-26
Medical Diagnostic Culture Media Recalled for Listeria Contamination
Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.
Product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2025·2025-02-26
Patient Warming Mattress Connector Cable Intermittent Connection Defect
Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2025·2025-02-26
RayStation radiation therapy planning software density uncertainty calculation inconsistency
RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in density uncertainty handling when HU-to-mass density CT calibration curves are used. No illnesses or injuries have been reported.
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2025·2025-02-26
Hot Dog Patient Warming Mattress Connector Cable Deflection Recall
Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1189-2025·2025-02-26
Radiation Therapy Planning System Density Calculation Inconsistency in RayStation
RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2025·2025-02-26
Medline Respiratory Intubation Kits Recalled for Reduced Skin Barrier Wear
Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.
Product
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1174-2025·2025-02-26
DeRoyal AMG Suction Connector Tubing connection may fail to seal
DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.
Product
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1173-2025·2025-02-26
Medline Medical Convenience Kits Recalled for Catheter Sterility Issue
Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.
Product
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1175-2025·2025-02-26
3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.
Product
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2025·2025-02-26
Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly
Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.
Product
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1177-2025·2025-02-26
Irix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates
XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.
Product
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1172-2025·2025-02-26
Augustine HotDog Return Electrode connector cables trigger contact error
Augustine Surgical Inc. is recalling HotDog Return Electrode connector cables (Model A138) that display a 'Check Neutral Electrode Contact' error message. The recall affects 7 units distributed to Alabama, Texas, and Nevada.
Product
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1180-2025·2025-02-26
Endotracheal Tube Fastener Recalled for Decreased Skin Barrier Wear
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
Product
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2025·2025-02-26
Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms
The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.
Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1194-2025·2025-02-26
Medical device recall: RayStation radiation therapy software dose calculation inconsistency
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Category
Medical Device
Distribution
Distributed nationwide

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3801–3825 of 13543