Class IIOngoingZ-0595-2026
Inpeco S.A. recalls FlexLab (FLX)
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results.…
Inpeco S.A.Dec 3, 2025
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 205–216 of 621 recalls
Class IIOngoingZ-0588-2026
Pivotal Health Solutions, Inc. recalls Quantum Intersegmental Table
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushi…
Pivotal Health Solutio…SDDec 3, 2025
Class IIOngoingZ-0587-2026
Pivotal Health Solutions, Inc. recalls Quantum Intersegmental Table
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushi…
Pivotal Health Solutio…SDDec 3, 2025
Class IIOngoingZ-0579-2026
Olympus Corporation Of The Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Ca…
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing.…
Olympus Corporation of…PADec 3, 2025
Class IIOngoingZ-0508-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catal…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0507-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Numb…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0506-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IIOngoingZ-0505-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits M…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec LLCCANov 26, 2025
Class IOngoingZ-0430-2026
CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate;…
CareFusion 303, Inc.CANov 26, 2025
Class IIOngoingZ-0499-2026
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
SHIMADZU CORPORATION M…Nov 19, 2025
Class IIOngoingZ-0480-2026
NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
NeuroLogica Corporatio…MANov 19, 2025
Class IIOngoingZ-0466-2026
Philips Medical Systems DMC GmbH recalls Radiography 7300 C
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e.…
Philips Medical System…Nov 19, 2025