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

1176–1200 of 13389

HighFDA (Devices)·Z-1068-2026·2026-01-21
[pending] Allura Xper FD10; Model Number: 722010;
Pending LLM rewrite. Source: FDA_DEVICE Z-1068-2026.
Product
Allura Xper FD10; Model Number: 722010;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2026·2026-01-21
[pending] Portex Spinal Tray, Item No. A3729-24 A3595
Pending LLM rewrite. Source: FDA_DEVICE Z-1101-2026.
Product
Portex Spinal Tray, Item No. A3729-24 A3595
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2026·2026-01-21
[pending] Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Pending LLM rewrite. Source: FDA_DEVICE Z-1038-2026.
Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1060-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1059-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1021-2026·2026-01-21
[pending] FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus s
Pending LLM rewrite. Source: FDA_DEVICE Z-1021-2026.
Product
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1067-2026·2026-01-21
[pending] Allura Xper FD20 Biplane; Model Number: 722008;
Pending LLM rewrite. Source: FDA_DEVICE Z-1067-2026.
Product
Allura Xper FD20 Biplane; Model Number: 722008;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2026·2026-01-21
[pending] Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 51506
Pending LLM rewrite. Source: FDA_DEVICE Z-1083-2026.
Product
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1095-2026·2026-01-21
[pending] The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test
Pending LLM rewrite. Source: FDA_DEVICE Z-1095-2026.
Product
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1099-2026·2026-01-21
[pending] CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 10
Pending LLM rewrite. Source: FDA_DEVICE Z-1099-2026.
Product
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2026·2026-01-21
[pending] Plum Duo Infusion System, List Number 40002-04-01
Pending LLM rewrite. Source: FDA_DEVICE Z-1094-2026.
Product
Plum Duo Infusion System, List Number 40002-04-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2026·2026-01-21
[pending] Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9
Pending LLM rewrite. Source: FDA_DEVICE Z-1098-2026.
Product
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2026·2026-01-21
[pending] Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm,
Pending LLM rewrite. Source: FDA_DEVICE Z-1042-2026.
Product
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2026·2026-01-21
[pending] Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1085-2026.
Product
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2026·2026-01-21
[pending] Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237
Pending LLM rewrite. Source: FDA_DEVICE Z-1087-2026.
Product
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2026·2026-01-21
[pending] SMV BodyTrack, System, Tomography, Computed, Emission
Pending LLM rewrite. Source: FDA_DEVICE Z-1046-2026.
Product
SMV BodyTrack, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1044-2026·2026-01-21
[pending] SMV DSX New Line, System, Tomography, Computed, Emission
Pending LLM rewrite. Source: FDA_DEVICE Z-1044-2026.
Product
SMV DSX New Line, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1056-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1056-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1053-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1072-2026·2026-01-21
[pending] Allura Xper FD20 OR Table; Model Number: 722023;
Pending LLM rewrite. Source: FDA_DEVICE Z-1072-2026.
Product
Allura Xper FD20 OR Table; Model Number: 722023;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2026·2026-01-21
[pending] Allura Xper FD20 Biplane; Model Number: 722013;
Pending LLM rewrite. Source: FDA_DEVICE Z-1071-2026.
Product
Allura Xper FD20 Biplane; Model Number: 722013;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2026·2026-01-21
[pending] Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-00
Pending LLM rewrite. Source: FDA_DEVICE Z-1092-2026.
Product
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1050-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1080-2026·2026-01-21
[pending] Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286
Pending LLM rewrite. Source: FDA_DEVICE Z-1080-2026.
Product
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable fo
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1047-2026·2026-01-21
[pending] MAXXUS, System, Tomography, Computed, Emission
Pending LLM rewrite. Source: FDA_DEVICE Z-1047-2026.
Product
MAXXUS, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states

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1176–1200 of 13389