Class IIOngoingZ-2460-2026
Accriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control
Assayed Whole blood control contains labeling with incorrect performance range.
Accriva Diagnostics, I…CAJun 24, 2026
Recalls in California
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 439 recalls
Class IIOngoingZ-2405-2026
Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 soft…
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Abbott MedicalCAJun 17, 2026
Class IIOngoingZ-2404-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318
Sterile anchors my lack sterility assurance.
Boston Scientific Neur…CAJun 17, 2026
Class IIOngoingZ-2403-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5
Reusable electrodes may not meet expected performance levels.
Boston Scientific Neur…CAJun 17, 2026
Class IIOngoingZ-2402-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10
Reusable electrodes may not meet expected performance levels.
Boston Scientific Neur…CAJun 17, 2026
Class IIOngoingZ-2310-2026
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic end…
Intuitive Surgical, In…CAJun 10, 2026
Class IIOngoingZ-2309-2026
SSC- Surgical Specialties Corporation recalls Sharpoint 2.2MM
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
SSC- Surgical Specialt…CAJun 10, 2026
Class IIOngoingZ-2304-2026
CareFusion 303, Inc. recalls BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
CareFusion 303, Inc.CAJun 10, 2026
Class IIOngoingZ-2303-2026
CareFusion 303, Inc. recalls BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
CareFusion 303, Inc.CAJun 10, 2026
Class IIOngoingZ-2302-2026
CareFusion 303, Inc. recalls BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
CareFusion 303, Inc.CAJun 10, 2026
Class IIOngoingZ-2301-2026
CareFusion 303, Inc. recalls BD Pyxis Mini Main REF: 349 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
CareFusion 303, Inc.CAJun 10, 2026
Class IIOngoingZ-2300-2026
CareFusion 303, Inc. recalls BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
CareFusion 303, Inc.CAJun 10, 2026