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

2176–2200 of 30649

HighFDA (Devices)·Z-1348-2026·2026-02-18
[pending] Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All
Pending LLM rewrite. Source: FDA_DEVICE Z-1348-2026.
Product
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1312-2026·2026-02-18
[pending] Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Pending LLM rewrite. Source: FDA_DEVICE Z-1312-2026.
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2026·2026-02-18
[pending] Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software
Pending LLM rewrite. Source: FDA_DEVICE Z-1349-2026.
Product
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1319-2026·2026-02-18
[pending] Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spaci
Pending LLM rewrite. Source: FDA_DEVICE Z-1319-2026.
Product
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2026·2026-02-18
[pending] Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - A
Pending LLM rewrite. Source: FDA_DEVICE Z-1346-2026.
Product
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2026·2026-02-18
[pending] Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Cathe
Pending LLM rewrite. Source: FDA_DEVICE Z-1325-2026.
Product
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2026·2026-02-18
[pending] Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Numb
Pending LLM rewrite. Source: FDA_DEVICE Z-1341-2026.
Product
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2026·2026-02-18
[pending] da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Pending LLM rewrite. Source: FDA_DEVICE Z-1355-2026.
Product
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Pending LLM rewrite. Source: FDA_DEVICE Z-1328-2026.
Product
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2026·2026-02-18
[pending] Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions:
Pending LLM rewrite. Source: FDA_DEVICE Z-1350-2026.
Product
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2026·2026-02-18
[pending] Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Pending LLM rewrite. Source: FDA_DEVICE Z-1338-2026.
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2026·2026-02-18
[pending] Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Softw
Pending LLM rewrite. Source: FDA_DEVICE Z-1345-2026.
Product
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1316-2026·2026-02-18
[pending] IQon Spectral CT; Product Code (REF): 728332;
Pending LLM rewrite. Source: FDA_DEVICE Z-1316-2026.
Product
IQon Spectral CT; Product Code (REF): 728332;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2026·2026-02-18
[pending] ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI c
Pending LLM rewrite. Source: FDA_DEVICE Z-1343-2026.
Product
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2026·2026-02-18
[pending] Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medica
Pending LLM rewrite. Source: FDA_DEVICE Z-1322-2026.
Product
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 40143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2026·2026-02-18
[pending] WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Pending LLM rewrite. Source: FDA_DEVICE Z-1337-2026.
Product
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2026·2026-02-18
[pending] Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number -
Pending LLM rewrite. Source: FDA_DEVICE Z-1344-2026.
Product
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Pending LLM rewrite. Source: FDA_DEVICE Z-1332-2026.
Product
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2026·2026-02-18
[pending] Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1357-2026.
Product
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1326-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Pending LLM rewrite. Source: FDA_DEVICE Z-1326-2026.
Product
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2026·2026-02-18
[pending] Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All
Pending LLM rewrite. Source: FDA_DEVICE Z-1347-2026.
Product
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2026·2026-02-18
[pending] Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Pending LLM rewrite. Source: FDA_DEVICE Z-1361-2026.
Product
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) P
Pending LLM rewrite. Source: FDA_DEVICE Z-1334-2026.
Product
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2026·2026-02-18
[pending] Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ver
Pending LLM rewrite. Source: FDA_DEVICE Z-1339-2026.
Product
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1351-2026·2026-02-18
[pending] Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-1351-2026.
Product
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide

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2176–2200 of 30649