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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2051–2075 of 39987

ModerateFDA (Devices)·Z-1050-2026·2026-01-21
Open heart kits recalled because they contain recalled B. Braun administration sets
Medline is recalling 633 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
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
LowFDA (Devices)·Z-1048-2026·2026-01-21
Infusion system software recalled to emphasize instructions in the manual
Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.
Product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1041-2026·2026-01-21
CT pendant upgrades recalled for missing a safe hand position label
Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1040-2026·2026-01-21
CT pendant replacement kits recalled for missing a safe hand position label
Mobius Imaging is recalling 101 detachable 10in pendant replacement components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Product
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1002-2026·2026-01-14
Mini Plus surgical kits recalled as not suitable for organ transplant
AVID Medical is recalling 380 Halyard Mini Plus Kit South units because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1000-2026·2026-01-14
Organ recovery packs recalled as not suitable for organ transplant
AVID Medical is recalling 132 Halyard Organ Recovery OR Packs, kit code LLOG1000-15, because the devices are not suitable for organ transplant.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1001-2026·2026-01-14
Organ recovery surgical packs recalled as not suitable for organ transplant
AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2026·2026-01-14
Oxygen masks recalled after complaints of tubing disconnecting during use
Medline is recalling 1,611,081 Hudson RCI medium concentration oxygen masks after multiple complaints of tubing disconnecting, which may lead to shortness of breath and hypoxia.
Product
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2026·2026-01-14
Medication dispensing servers recalled over delayed updates from enterprise systems
CareFusion 303 is recalling 2,079 BD Pyxis ES Enterprise Server systems over a software issue that may result in equipment not receiving timely updates of patient or medication information.
Product
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2026·2026-01-14
Patient monitors recalled over unvalidated intracranial and bladder pressure measurements
Remote Diagnostic Technologies is recalling 7,129 Philips Tempus Pro Patient Monitors because intracranial and bladder pressure measurements have not been tested or validated for accuracy.
Product
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2026·2026-01-14
Arial call stations recalled over a firmware issue affecting battery alerts
Securitas Healthcare is recalling 5,627 Arial 900 MHz Call Stations, model CSK200-900, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.
Product
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2026·2026-01-14
C. difficile assay recalled over declining performance and false negative results
Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2026·2026-01-14
Thyroid receptor immunoassay recalled over variable results across instrument platforms
Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or treatment.
Product
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocompl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2026·2026-01-14
Emergency call stations recalled over missing low battery alerts
Securitas Healthcare is recalling 1,898 Arial 900 MHz Call Stations, model CSK200-900MR, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.
Product
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2026·2026-01-14
Head fixation devices recalled because a torque screw may crack or separate
IMRIS Imaging is recalling 122 HFD100 Head Fixation Devices because a torque screw may crack or separate, which could lead to inadequate head stabilization and risk of patient injury.
Product
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2026·2026-01-14
Telemetry monitors recalled over a failure to reconnect between access points
Philips North America is recalling 13,470 Smart-hopping 2.0 AP 1.4 GHz patient monitors because the MX40 could not reconnect to the PIC iX when signal strength changed quickly.
Product
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1037-2026·2026-01-14
CereLink pressure sensor kits recalled over corrosion stains on the needle
Integra LifeSciences is recalling 5,116 Codman CereLink ICP Sensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
Product
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transduc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1025-2026·2026-01-14
DxI 600 immunoassay analyzers recalled over a failure to restart after shutdown
Beckman Coulter is recalling 1,272 UniCel DxI 600 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1003-2026·2026-01-14
Incisive CT systems recalled over an unstable connection inside the floating sensor
Philips Healthcare (Suzhou) is recalling 35 Incisive CT systems over the potential for an incomplete scan due to an unstable connection inside the floating sensor.
Product
Philips Incisive CT
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0999-2026·2026-01-14
Radiography systems recalled because collimation may be incorrect between programs
Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1029-2026·2026-01-14
Intracranial pressure monitors recalled after customer complaints of rebooting
Sophysa is recalling 105 Pressio 2 ICP Monitoring Systems following customer complaints of the Pressio monitor rebooting.
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1036-2026·2026-01-14
Intracranial pressure monitoring kits recalled over corrosion stains on the needle
Integra LifeSciences is recalling 1,301 Codman Microsensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
Product
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1010-2026·2026-01-14
Laparoscopic trocars recalled over a potentially extended blade obturator length
Applied Medical Resources is recalling 450 units of the Kii Low Profile Bladed Dual Pack because of the potential for extended length of the blade obturator after assembly.
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1030-2026·2026-01-14
Heart pump sets recalled after being packaged in the wrong outer carton
Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1026-2026·2026-01-14
DxI 800 immunoassay analyzers recalled over a failure to restart after shutdown
Beckman Coulter is recalling 6,457 UniCel DxI 800 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.
Product
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

2051–2075 of 39987