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Chromophare Surgical Light (Stryker) – Mounting Stability Risk (2024)

Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

FDAFeb 8, 2024Nationwide• Stryker Communications

CLEARLINK Solution Adapter (Baxter) – Potential Leak Risk (2024)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

Moderate

FDAFeb 8, 2024Nationwide• Baxter Healthcare Corporation

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Chromophare Surgical Light (Stryker) – Mounting Stability Risk (2024)

CLEARLINK Solution Adapter (Baxter) – Potential Leak Risk (2024)

Access Total T4 (Beckman Coulter) – Reagent Imprecision (2024)

VERIQA Software (PTW-Freiburg) – Gamma Calculation Issue (2024)

Access Substrate (Beckman Coulter) – Lot Imprecision (2024)

paraPAC Plus Ventilator (Smiths Medical) – Gas Flow Problem (2024)

Torrent Suite Dx Software (Life Technologies) – Vulnerability Risk (2024)

TENSIVE Conductive Adhesive Gel (Natus) – Supplier Recall (2024)

DCA HbA1c Reagent Kit (Siemens) – Test Result Bias (2024)

DLP Vessel Cannula (Medtronic) – Labeling Error (2024)

Sleep Supplies Start Kit (Natus) – Adhesive Gel Concern (2024)

Triathlon TS Plus Insert (Howmedica) – Packaging Breach (2024)

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Azurion 3 (Philips) – Generator Failure Risk (2024)

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Triathlon TS Plus Insert (Howmedica) – Packaging Breach (2024)

Azurion 5 (Philips) – Generator Failure Risk (2024)

SPII Lubinus Prosthesis (Waldemar Link) – Labeling Confusion (2024)

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)