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

1951–1975 of 39948

HighFDA (Devices)·Z-1109-2026·2026-01-28
RayStation 2024B treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1124-2026·2026-01-28
Angiographic inflation devices recalled over handles that may detach
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.
Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
RayStation 10B SP1 recalled over radiation dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1121-2026·2026-01-28
SIGMA Spectrum infusion pumps recalled over defective grease on the gears
Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2026·2026-01-28
Needle free access connectors recalled over silicone seals that may tear
ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2026·2026-01-28
PET scanners recalled over a streaking artifact in clinical images
GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.
Product
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2026·2026-01-28
Robotic guidance systems recalled over incorrect surgical instrument positioning errors
Mazor Robotics is recalling 549 Mazor X robotic guidance systems over software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Product
Mazor X robotic guidance system REF: TPL0059
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2026·2026-01-28
RayStation 11B treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan models 12.0.0, 12.1.0, 12.0.3, 12.0.4 and 12.3.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1105-2026·2026-01-28
RayStation 12A treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan models 13.0.0.1547, 13.1.0.144 and 13.1.1.89 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1110-2026·2026-01-28
RayStation v2025 treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan models 17.0.0 and 17.0.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1126-2026·2026-01-28
Custom inflation kits recalled over inflation handles that may detach
Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2026·2026-01-28
Custom procedure kits recalled over inflation handles that may detach
Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2026·2026-01-28
Angioplasty packs recalled over inflation handles that may detach
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1133-2026·2026-01-28
Reusable hip trial components recalled over missing FDA premarket authorization
MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.
Product
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-1155-2026·2026-01-28
Telemetry transmitters recalled over potential cybersecurity issues flagged by FDA
Edan Diagnostics is recalling 1,457 units of its iT20 Telemetry Transmitter after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The para
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1120-2026·2026-01-28
Plum Solo pumps recalled over hard limit messages blocking flush programming
ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Product
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1144-2026·2026-01-28
iM3s series vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1141-2026·2026-01-28
Fetal and maternal monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 3,518 units of its Fetal & Maternal Monitor models F6, F9, F6 Express and F9 Express after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1142-2026·2026-01-28
M3 vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 13,934 units of its M3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-inv
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1154-2026·2026-01-28
iM8 series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and cont
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1139-2026·2026-01-28
Gait training devices recalled over potential fraying on the body support strap
Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.
Product
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1152-2026·2026-01-28
M3B vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1132-2026·2026-01-28
Long distal radius plates recalled over an incorrect thread orientation
Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1137-2026·2026-01-28
TRAM powered lift devices recalled over potential strap fraying
Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.
Product
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1149-2026·2026-01-28
iX series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing
Category
Medical Device
Distribution
Distributed nationwide

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1951–1975 of 39948