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ImmunoCard Crypto/Giardia Test (Medline) – Storage Temperature Concern (2025)

A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.

Low

FDAMar 24, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Connex Accessory Power Management Stand (Baxter) – Battery Fire Risk (2025)

Fire/Burn Risk

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

High

FDAMar 24, 2025Nationwide• Baxter Healthcare Corporation

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ImmunoCard Crypto/Giardia Test (Medline) – Storage Temperature Concern (2025)

Connex Accessory Power Management Stand (Baxter) – Battery Fire Risk (2025)

Intera 1.5T R11 (Philips) – Coil Seal Adhesive Failure (2025)

CareStation 650 A1 (GE Healthcare) – ventilation ineffective (2025)

CareStation 750c A1 (GE Healthcare) – ventilation ineffective (2025)

Connex Vital Signs Monitor (Baxter) – undeclared rubber band (2025)

OEC Elite (GE Medical) – X-ray field distance issue (2025)

CareStation 620 A1 (GE Healthcare) – ventilation ineffective (2025)

Green Series 777 Wall System (Baxter) – undeclared rubber band (2025)

ABL90 Series (Radiometer) – analyzer freeze risk (2025)

DuraShock Aneroid Gauge (Baxter) – undeclared rubber band (2025)

Connex Spot Monitor (Baxter) – undeclared rubber band (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

OEC 3D (GE Medical) – X-ray field distance issue (2025)

CareStation 650C A1 (GE Healthcare) – ventilation ineffective (2025)

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Methocarbamol Injection (Somerset) – Sterility Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)