Class IIOngoingZ-3335-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
Siemens Healthcare Dia…NYOct 7, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 674 recalls
Class IIOngoingZ-3331-2026
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra Syste…
Due to manufacturing issues reperfusion catheters may fracture.
Penumbra Inc.CAOct 7, 2026
Class IIOngoingZ-3329-2026
Olympus Corporation Of The Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
Olympus Corporation of…PAOct 7, 2026
Class IIOngoingZ-3326-2026
Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code:…
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
Micro Therapeutics, I…CAOct 7, 2026
Class IIOngoingZ-3304-2026
Heraeus Medical GmbH (Dental Division) recalls PALACOS MV pro 40
Potential for monomer liquid leakage.
Heraeus Medical GmbH (…Oct 7, 2026
Class IIOngoingZ-3303-2026
Heraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40
Potential for monomer liquid leakage.
Heraeus Medical GmbH (…Oct 7, 2026
Class IIOngoingZ-3302-2026
Heraeus Medical GmbH (Dental Division) recalls PALACOS R+G pro 40
Potential for monomer liquid leakage.
Heraeus Medical GmbH (…Oct 7, 2026
Class IIOngoingZ-3301-2026
Heraeus Medical GmbH (Dental Division) recalls PALACOS R pro 40
Potential for monomer liquid leakage.
Heraeus Medical GmbH (…Oct 7, 2026
Class IIOngoingZ-3298-2026
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor.…
Cardinal Health 200, L…ILOct 7, 2026
Class IIOngoingZ-3297-2026
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor.…
Cardinal Health 200, L…ILOct 7, 2026
Class IIOngoingZ-3296-2026
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor.…
Cardinal Health 200, L…ILOct 7, 2026
Class IIOngoingZ-3295-2026
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor.…
Cardinal Health 200, L…ILOct 7, 2026