Class IOngoingZ-2181-2025
Ambu Inc. recalls Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator
Potential for the manometer port being blocked rendering the manometer non-functional.
Ambu Inc.MDAug 20, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,345–1,356 of 2,908 recalls
Class IOngoingZ-2173-2025
Baxter Healthcare Corporation recalls Baxter Novum IQ Large Volume Pump
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double.…
Baxter Healthcare Corp…ILAug 20, 2025
Class IIOngoingZ-2277-2025
Stryker Corporation recalls Stryker SmartPump Tourniquet
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected.…
Stryker CorporationMIAug 13, 2025
Class IIOngoingZ-2276-2025
Intersurgical Inc recalls One-piece Guedel airway
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Intersurgical IncNYAug 13, 2025
Class IIOngoingZ-2275-2025
Intersurgical Inc recalls One-piece Guedel airway
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Intersurgical IncNYAug 13, 2025
Class IIOngoingZ-2274-2025
Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-1…
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Process control
Nuclein LLCTXAug 13, 2025
Class IIOngoingZ-2272-2025
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…
Siemens Healthcare Dia…MAAug 13, 2025
Class IIOngoingZ-2271-2025
Beckman Coulter, Inc. recalls DxI 600 Access Immunoassay Analyzer W/Spot B
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
Beckman Coulter, Inc.MNAug 13, 2025
Class IIOngoingZ-2270-2025
Beckman Coulter, Inc. recalls DxI 600 Access Immunoassay Analyzer W/Dual Gantry
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
Beckman Coulter, Inc.MNAug 13, 2025
Class IIOngoingZ-2269-2025
Beckman Coulter, Inc. recalls UniCel DxI 600 Access Immunoassay Analyzer
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
Beckman Coulter, Inc.MNAug 13, 2025
Class IIOngoingZ-2268-2025
Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Spot B
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
Beckman Coulter, Inc.MNAug 13, 2025
Class IIOngoingZ-2267-2025
Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Dual Gantry
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
Beckman Coulter, Inc.MNAug 13, 2025