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

1201–1225 of 13381

ModerateFDA (Devices)·Z-1059-2026·2026-01-21
Medline IV Administration Sets Recalled for Stuck Check Valve
Medline has recalled Neuro Angio Packs containing B. Braun IV and pump administration sets because check valve components may become stuck in open or closed positions, potentially affecting medication delivery.
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
ModerateFDA (Devices)·Z-1070-2026·2026-01-21
Philips X-ray system cooling drip tray missing in limited units
In limited Allura Xper FD20 X-ray systems, the cooling unit drip tray was not installed or inadequately documented. This creates a potential for coolant to contact electrical components and trigger system shutdown.
Product
Allura Xper FD20; Model Number: 722012;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1077-2026·2026-01-21
Philips Allura Xper FD20/20 Imaging System Cooling Tray Installation Defect
Philips is recalling select Allura Xper FD20/20 imaging systems where the cooling unit drip tray may not be installed. If not installed, coolant could contact electrical components and cause system shutdown.
Product
Allura Xper FD20/20; Model Number: 722038;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1061-2026·2026-01-21
BD Hydrophilic Catheter 14 Fr recall due to incorrect expiration date on label
BD Ready-to-Use Hydrophilic Catheters (14 Fr, Straight Tip, Female) are being recalled due to incorrect expiration date labeling. The recall affects 149,310 units distributed in Georgia.
Product
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1091-2026·2026-01-21
Philips Azurion medical imaging systems recalled for software defects
Philips is recalling Azurion diagnostic imaging systems with software versions R2.1.10 and R2.2.10 due to six software defects that may cause system restarts, storage issues, and positioning errors. Approximately 10,466 units distributed worldwide are affected.
Product
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1082-2026·2026-01-21
Bone cement ampoules may fail to break, preventing surgical use
Heraeus Medical is recalling PALACOS MV+G pro bone cement due to ampoules that may fail to break properly, preventing product use. Affected units were distributed internationally.
Product
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1001-2026·2026-01-14
Organ recovery kit unsuitable for organ transplant purposes
The Halyard organ recovery kit was recalled because the devices are unsuitable for organ transplant.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1002-2026·2026-01-14
Halyard MINI PLUS KIT SOUTH Recalled Due to Organ Transplant Unsuitability
AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1000-2026·2026-01-14
Halyard Organ Recovery Kit Recalled Due to Device Unsuitability
AVID Medical recalls 132 units of the Halyard ORGAN RECOVERY OR PACK (Kit Code: LLOG1000-15) due to device unsuitability for organ transplant. The recalled units were distributed nationwide in Florida, Georgia, and Puerto Rico.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2026·2026-01-14
Surgical blade instruments recalled for potential assembly defect
Applied Medical Resources is recalling 450 units of Kii Low Profile surgical instruments due to a potential blade obturator assembly defect that could affect surgical performance.
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1034-2026·2026-01-14
Head Fixation Device screws may crack or separate during surgery
The HFD100 Head Fixation Device's torque screws may crack or separate during surgical use, potentially compromising head stabilization. IMRIS is recalling 122 affected units distributed worldwide.
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-1019-2026·2026-01-14
Revogene C. difficile Diagnostic Assay Recalled for Performance Decline Risk
Meridian Bioscience is recalling Revogene C. difficile diagnostic assays (211 units) due to performance decline that may cause false-negative test results. Affected lots were distributed nationwide and in Italy.
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
Elecsys Anti-TSHR Immunoassay Recalled for Diagnostic Test Result Variability
Roche is recalling 1,300 cassettes of the Elecsys Anti-TSHR immunoassay due to inconsistent test results across instrument platforms and lot-to-lot calibrator variability. These issues may cause delayed or incorrect diagnosis and 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
Call Station Firmware Issue May Prevent Low Battery Alert Transmission
Certain Arial 900 MHz wireless call stations (Model CSK200-900MR) may fail to alert users about low battery conditions before the device loses power. Approximately 1,898 affected units were distributed in the US and Canada.
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-1037-2026·2026-01-14
Codman CereLink ICP Sensor Kit recalled for potential needle corrosion
Integra LifeSciences is recalling 5,116 units of the Codman CereLink ICP Sensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy needle. The kit is used for intracranial pressure monitoring.
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
HighFDA (Devices)·Z-1031-2026·2026-01-14
Medical Device Call Station Firmware Issue May Prevent Battery Alerts
Securitas Healthcare recalled 5,627 Arial 900 MHz Call Stations with a firmware issue that prevents timely low battery alerts to the wireless emergency call system.
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-1027-2026·2026-01-14
Philips Tempus Pro Patient Monitor Unvalidated Measurement Recall
FDA recalls Philips Tempus Pro Patient Monitors because intracranial pressure and bladder pressure measurements have not been tested or validated for accuracy. Healthcare providers using unvalidated measurements could make incorrect clinical decisions.
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-0999-2026·2026-01-14
LUMINOS Lotus Max and dRF Max Systems: Collimation Software Error
Siemens LUMINOS Lotus Max and dRF Max fluoroscopy systems with software version VF11 may display incorrect collimation when rapidly switching between organ programs. The defect affects devices with bucky wall stands for mobile detectors.
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1033-2026·2026-01-14
Philips Patient Monitor May Lose Wireless Connection Between Access Points
Philips patient monitors may fail to reconnect to associated devices when moving between wireless access points with rapidly changing signal strength, potentially interrupting patient monitoring.
Product
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2026·2026-01-14
Pressio 2 ICP Monitor Recalled for Unexpected Rebooting
Sophysa is recalling 105 units of the Pressio 2 ICP Monitoring System due to customer complaints of unexpected rebooting. The malfunction could interrupt critical patient monitoring.
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2026·2026-01-14
ICP Monitoring Device Recall: Potential Needle Corrosion in Codman Microsensor Kit
Integra LifeSciences is recalling the Codman Microsensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy Needle. This device is used for intracranial pressure monitoring and corrosion could affect its function.
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
HighFDA (Devices)·Z-1003-2026·2026-01-14
Philips Incisive CT scanners recalled for potential incomplete scans
Philips Incisive CT scanners may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare facilities should not operate affected devices until repair is arranged with the manufacturer.
Product
Philips Incisive CT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1028-2026·2026-01-14
BD Pyxis ES Enterprise Server Software Defect May Delay Medication Updates
A software issue in the BD Pyxis ES Enterprise Server may prevent timely updates of patient and medication information. The defect affects 2,079 systems distributed nationwide and in Canada and Bermuda.
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-1035-2026·2026-01-14
Medline oxygen masks recalled due to tubing disconnection risk
Medline Hudson RCI oxygen masks may experience tubing disconnection during use, potentially delaying patient care and causing hypoxia. The company has received multiple complaints about this defect.
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
ModerateFDA (Devices)·Z-1025-2026·2026-01-14
Beckman Coulter Analyzer May Fail to Restart After Shutdown
Beckman Coulter's UniCel DxL 600 analyzer may fail to restart after shutdown due to a communication issue, preventing sample processing and causing delayed results. 1,272 units recalled worldwide.
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide

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