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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1076–1100 of 13390

HighFDA (Devices)·Z-1185-2026·2026-02-04
[pending] Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, a
Pending LLM rewrite. Source: FDA_DEVICE Z-1185-2026.
Product
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2026·2026-02-04
[pending] Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta
Pending LLM rewrite. Source: FDA_DEVICE Z-1164-2026.
Product
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1198-2026·2026-02-04
[pending] Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Pending LLM rewrite. Source: FDA_DEVICE Z-1198-2026.
Product
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1217-2026·2026-02-04
[pending] BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardr
Pending LLM rewrite. Source: FDA_DEVICE Z-1217-2026.
Product
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clini
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1110-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Soft
Pending LLM rewrite. Source: FDA_DEVICE Z-1110-2026.
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-1106-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1
Pending LLM rewrite. Source: FDA_DEVICE Z-1106-2026.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1140-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: Th
Pending LLM rewrite. Source: FDA_DEVICE Z-1140-2026.
Product
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2026·2026-01-28
[pending] Philips Azurion system; Software Version Number: R3.1;
Pending LLM rewrite. Source: FDA_DEVICE Z-1113-2026.
Product
Philips Azurion system; Software Version Number: R3.1;
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1142-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description:
Pending LLM rewrite. Source: FDA_DEVICE Z-1142-2026.
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
HighFDA (Devices)·Z-1108-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Soft
Pending LLM rewrite. Source: FDA_DEVICE Z-1108-2026.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1109-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Ver
Pending LLM rewrite. Source: FDA_DEVICE Z-1109-2026.
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
[pending] Allwell Inflation Device, for angiographic use REF: IS-30-A
Pending LLM rewrite. Source: FDA_DEVICE Z-1124-2026.
Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Li
Pending LLM rewrite. Source: FDA_DEVICE Z-1151-2026.
Product
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2026·2026-01-28
[pending] MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Pending LLM rewrite. Source: FDA_DEVICE Z-1015-2026.
Product
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1153-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description:
Pending LLM rewrite. Source: FDA_DEVICE Z-1153-2026.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A 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-in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2026·2026-01-28
[pending] Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130
Pending LLM rewrite. Source: FDA_DEVICE Z-1123-2026.
Product
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Descripti
Pending LLM rewrite. Source: FDA_DEVICE Z-1155-2026.
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
HighFDA (Devices)·Z-1014-2026·2026-01-28
[pending] MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Pending LLM rewrite. Source: FDA_DEVICE Z-1014-2026.
Product
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1149-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Des
Pending LLM rewrite. Source: FDA_DEVICE Z-1149-2026.
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
HighFDA (Devices)·Z-1118-2026·2026-01-28
[pending] ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Pending LLM rewrite. Source: FDA_DEVICE Z-1118-2026.
Product
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2026·2026-01-28
[pending] Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Pending LLM rewrite. Source: FDA_DEVICE Z-1111-2026.
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-1120-2026·2026-01-28
[pending] ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Pending LLM rewrite. Source: FDA_DEVICE Z-1120-2026.
Product
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1146-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8
Pending LLM rewrite. Source: FDA_DEVICE Z-1146-2026.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2026·2026-01-28
[pending] GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI L
Pending LLM rewrite. Source: FDA_DEVICE Z-1112-2026.
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-1013-2026·2026-01-28
[pending] MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic
Pending LLM rewrite. Source: FDA_DEVICE Z-1013-2026.
Product
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Category
Medical Device
Distribution
3 states

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1076–1100 of 13390