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

1126–1150 of 13390

HighFDA (Devices)·Z-1148-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Descrip
Pending LLM rewrite. Source: FDA_DEVICE Z-1148-2026.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) 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-1131-2026·2026-01-28
[pending] Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaf
Pending LLM rewrite. Source: FDA_DEVICE Z-1131-2026.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2026·2026-01-28
[pending] Mazor X robotic guidance system REF: TPL0059
Pending LLM rewrite. Source: FDA_DEVICE Z-1122-2026.
Product
Mazor X robotic guidance system REF: TPL0059
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2026·2026-01-28
[pending] The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solub
Pending LLM rewrite. Source: FDA_DEVICE Z-1135-2026.
Product
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1134-2026·2026-01-28
[pending] Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127
Pending LLM rewrite. Source: FDA_DEVICE Z-1134-2026.
Product
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1102-2026·2026-01-28
[pending] RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radia
Pending LLM rewrite. Source: FDA_DEVICE Z-1102-2026.
Product
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1141-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express,
Pending LLM rewrite. Source: FDA_DEVICE Z-1141-2026.
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
HighFDA (Devices)·Z-1138-2026·2026-01-28
[pending] Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device fo
Pending LLM rewrite. Source: FDA_DEVICE Z-1138-2026.
Product
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. 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. The low base variant includes smaller casters and lower base frame so that th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Produ
Pending LLM rewrite. Source: FDA_DEVICE Z-1145-2026.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2026·2026-01-28
[pending] MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic
Pending LLM rewrite. Source: FDA_DEVICE Z-1011-2026.
Product
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1147-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: Th
Pending LLM rewrite. Source: FDA_DEVICE Z-1147-2026.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-inv
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
[pending] SQ40S Blood Transfusion Filter
Pending LLM rewrite. Source: FDA_DEVICE Z-1157-2026.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1078-2026·2026-01-21
[pending] MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Pending LLM rewrite. Source: FDA_DEVICE Z-1078-2026.
Product
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2026·2026-01-21
[pending] VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Pending LLM rewrite. Source: FDA_DEVICE Z-1017-2026.
Product
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1090-2026·2026-01-21
[pending] Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL1
Pending LLM rewrite. Source: FDA_DEVICE Z-1090-2026.
Product
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2026·2026-01-21
[pending] da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) &
Pending LLM rewrite. Source: FDA_DEVICE Z-1096-2026.
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2026·2026-01-21
[pending] BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Pending LLM rewrite. Source: FDA_DEVICE Z-1061-2026.
Product
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1063-2026·2026-01-21
[pending] Allura Xper FD10F; Model Number: 722002;
Pending LLM rewrite. Source: FDA_DEVICE Z-1063-2026.
Product
Allura Xper FD10F; Model Number: 722002;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1054-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2026·2026-01-21
[pending] Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 508
Pending LLM rewrite. Source: FDA_DEVICE Z-1081-2026.
Product
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1043-2026·2026-01-21
[pending] A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product numb
Pending LLM rewrite. Source: FDA_DEVICE Z-1043-2026.
Product
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2026·2026-01-21
[pending] Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Pending LLM rewrite. Source: FDA_DEVICE Z-1039-2026.
Product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1055-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2026·2026-01-21
[pending] Allura Xper FD20; Model Number: 722028;
Pending LLM rewrite. Source: FDA_DEVICE Z-1075-2026.
Product
Allura Xper FD20; Model Number: 722028;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2026·2026-01-21
[pending] Allura Xper FD10/10; Model Number: 722027;
Pending LLM rewrite. Source: FDA_DEVICE Z-1074-2026.
Product
Allura Xper FD10/10; Model Number: 722027;
Category
Medical Device
Distribution
Distributed nationwide

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1126–1150 of 13390