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

901–925 of 13390

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
HighFDA (Devices)·Z-1360-2026·2026-02-18
[pending] Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1360-2026.
Product
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2026·2026-02-18
[pending] Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1356-2026.
Product
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1313-2026·2026-02-18
[pending] Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Pending LLM rewrite. Source: FDA_DEVICE Z-1313-2026.
Product
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2026·2026-02-18
[pending] ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI c
Pending LLM rewrite. Source: FDA_DEVICE Z-1342-2026.
Product
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; 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-1335-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Pending LLM rewrite. Source: FDA_DEVICE Z-1335-2026.
Product
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2026·2026-02-18
[pending] Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Pending LLM rewrite. Source: FDA_DEVICE Z-1314-2026.
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2026·2026-02-18
[pending] Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUN
Pending LLM rewrite. Source: FDA_DEVICE Z-1324-2026.
Product
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Bios
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) L
Pending LLM rewrite. Source: FDA_DEVICE Z-1329-2026.
Product
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2026·2026-02-18
[pending] 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit
Pending LLM rewrite. Source: FDA_DEVICE Z-1330-2026.
Product
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2026·2026-02-18
[pending] Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electro
Pending LLM rewrite. Source: FDA_DEVICE Z-1321-2026.
Product
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Cath
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Pending LLM rewrite. Source: FDA_DEVICE Z-1333-2026.
Product
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Pending LLM rewrite. Source: FDA_DEVICE Z-1327-2026.
Product
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2026·2026-02-18
[pending] Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D0
Pending LLM rewrite. Source: FDA_DEVICE Z-1323-2026.
Product
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2026·2026-02-18
[pending] Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Pending LLM rewrite. Source: FDA_DEVICE Z-1336-2026.
Product
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2026·2026-02-18
[pending] Spectral CT 7500 on Rails; Product Code (REF): 728334;
Pending LLM rewrite. Source: FDA_DEVICE Z-1318-2026.
Product
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2026·2026-02-11
[pending] Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX V
Pending LLM rewrite. Source: FDA_DEVICE Z-1249-2026.
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1221-2026·2026-02-11
[pending] COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffer
Pending LLM rewrite. Source: FDA_DEVICE Z-1221-2026.
Product
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1290-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1290-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1287-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1287-2026.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide

Filters

901–925 of 13390