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

1901–1925 of 13384

HighFDA (Devices)·Z-0308-2026·2025-11-05
[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0308-2026.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2026·2025-11-05
[pending] All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Pending LLM rewrite. Source: FDA_DEVICE Z-0371-2026.
Product
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2026·2025-11-05
[pending] Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00
Pending LLM rewrite. Source: FDA_DEVICE Z-0367-2026.
Product
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0234-2026·2025-10-29
[pending] Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefill
Pending LLM rewrite. Source: FDA_DEVICE Z-0234-2026.
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0243-2026·2025-10-29
[pending] MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0243-2026.
Product
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0248-2026·2025-10-29
[pending] Model Number 40KWFXPLUS.004, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0248-2026.
Product
Model Number 40KWFXPLUS.004, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0293-2026·2025-10-29
[pending] Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0293-2026.
Product
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0233-2026·2025-10-29
[pending] Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product code
Pending LLM rewrite. Source: FDA_DEVICE Z-0233-2026.
Product
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0255-2026·2025-10-29
[pending] Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0255-2026.
Product
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0208-2026·2025-10-29
[pending] Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stoma
Pending LLM rewrite. Source: FDA_DEVICE Z-0208-2026.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0270-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0221-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS
Pending LLM rewrite. Source: FDA_DEVICE Z-0221-2026.
Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0224-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography
Pending LLM rewrite. Source: FDA_DEVICE Z-0224-2026.
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0207-2026·2025-10-29
[pending] Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12
Pending LLM rewrite. Source: FDA_DEVICE Z-0207-2026.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0230-2026·2025-10-29
[pending] Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS2000
Pending LLM rewrite. Source: FDA_DEVICE Z-0230-2026.
Product
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0232-2026·2025-10-29
[pending] t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071,
Pending LLM rewrite. Source: FDA_DEVICE Z-0232-2026.
Product
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0277-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0277-2026.
Product
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0241-2026·2025-10-29
[pending] Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0241-2026.
Product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0299-2026·2025-10-29
[pending] Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0299-2026.
Product
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0271-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0271-2026.
Product
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0284-2026·2025-10-29
[pending] SM_40HF_B_D_VIR3, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0284-2026.
Product
SM_40HF_B_D_VIR3, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0287-2026·2025-10-29
[pending] SM_40HF_BDC3, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0287-2026.
Product
SM_40HF_BDC3, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0254-2026·2025-10-29
[pending] Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0254-2026.
Product
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0211-2026·2025-10-29
[pending] Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube,
Pending LLM rewrite. Source: FDA_DEVICE Z-0211-2026.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2026·2025-10-29
[pending] GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part
Pending LLM rewrite. Source: FDA_DEVICE Z-0214-2026.
Product
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
Category
Medical Device
Distribution
0 states

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1901–1925 of 13384