Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 76 - 87 of 87 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	FDA Z-1023-2026	Medical Device	High	Jan 21, 2026 Recall: Nov 24, 2025	Details
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	FDA Z-1022-2026	Medical Device	High	Jan 21, 2026 Recall: Nov 24, 2025	Details
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy. Potential for microbial contamination.	FDA Z-1095-2026	Medical Device	High	Jan 21, 2026 Recall: Dec 11, 2025	Details
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. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	FDA Z-1021-2026	Medical Device	High	Jan 21, 2026 Recall: Nov 24, 2025	Details
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	FDA Z-1020-2026	Medical Device	High	Jan 21, 2026 Recall: Nov 24, 2025	Details
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.	FDA Z-1079-2026	Medical Device	High	Jan 21, 2026 Recall: Dec 8, 2025	Details
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 transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also av Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.	FDA Z-1037-2026	Medical Device	High	Jan 14, 2026 Recall: Dec 12, 2025	Details
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.	FDA Z-1033-2026	Medical Device	High	Jan 14, 2026 Recall: Dec 12, 2025	Details
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 Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.	FDA Z-1027-2026	Medical Device	High	Jan 14, 2026 Recall: Nov 26, 2025	Details
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor Customer complaints of Pressio monitor rebooting.	FDA Z-1029-2026	Medical Device	High	Jan 14, 2026 Recall: Nov 17, 2025	Details
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. Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.	FDA Z-1036-2026	Medical Device	High	Jan 14, 2026 Recall: Dec 12, 2025	Details
BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).	FDA Z-1008-2026	Medical Device	High	Jan 7, 2026 Recall: Dec 5, 2025	Details

Showing 76 - 87 of 87 product recalls

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Medical Device Recalls Today

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