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

1976–2000 of 13384

HighFDA (Devices)·Z-0259-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0259-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0251-2026·2025-10-29
[pending] Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0251-2026.
Product
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0273-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0273-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0289-2026·2025-10-29
[pending] Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Pending LLM rewrite. Source: FDA_DEVICE Z-0289-2026.
Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0264-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0264-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0290-2026·2025-10-29
[pending] Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0290-2026.
Product
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0217-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD
Pending LLM rewrite. Source: FDA_DEVICE Z-0217-2026.
Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0212-2026·2025-10-29
[pending] BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation Sys
Pending LLM rewrite. Source: FDA_DEVICE Z-0212-2026.
Product
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0263-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0263-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0272-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0272-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0215-2026·2025-10-29
[pending] DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500
Pending LLM rewrite. Source: FDA_DEVICE Z-0215-2026.
Product
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0276-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0276-2026.
Product
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0246-2026·2025-10-29
[pending] Model Number 40KWFXPLUS, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0246-2026.
Product
Model Number 40KWFXPLUS, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0229-2026·2025-10-29
[pending] LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used i
Pending LLM rewrite. Source: FDA_DEVICE Z-0229-2026.
Product
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0261-2026·2025-10-29
[pending] Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0261-2026.
Product
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0266-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0266-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0296-2026·2025-10-29
[pending] Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0296-2026.
Product
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0222-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography
Pending LLM rewrite. Source: FDA_DEVICE Z-0222-2026.
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0258-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0258-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0244-2026·2025-10-29
[pending] Model Number 40KWFX, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0244-2026.
Product
Model Number 40KWFX, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0238-2026·2025-10-29
[pending] BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD
Pending LLM rewrite. Source: FDA_DEVICE Z-0238-2026.
Product
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0280-2026.
Product
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0256-2026·2025-10-29
[pending] Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0256-2026.
Product
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0301-2026·2025-10-29
[pending] Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0301-2026.
Product
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0239-2026·2025-10-29
[pending] BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology Sys
Pending LLM rewrite. Source: FDA_DEVICE Z-0239-2026.
Product
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Category
Medical Device
Distribution
Distributed nationwide

Filters

1976–2000 of 13384