This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Fresenius Kabi USA has…
Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure
The devices described in this recall are the same devices announced in the related Letter to Health Care Providers. On November 8, 2024 the FDA issued an update to the Letter to Health Care Providers to provide the most recent recommendations provided by GE HealthCare. This recall involves updating instructions for using devices, and does…
Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Pack (extended…
Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Name: MiniCap Extended Life PD Transfer…
Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: microTargeting Insertion Tube Set Unique Device Identifier (UDI)/Product Model: 10873263004323/66-IT-05P Lot Number: 244517…
Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Name: AK 98 Hemodialysis Machine Unique…
Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Elekta Disposable Biopsy Needle Kit Unique Device Identifier (UDI): Package including 6 needles:…
Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product Product Names:…
Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Atlan A350 and Atlan…
Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Products Product Names:…