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Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Moderate
FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC
Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Moderate
FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Moderate
FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Snap Hair Clips (YFLGOTOO) – Lead Poisoning Risk (2025)
This recall involves Dlesot Snap Hair Clips. The metal hair clips are in a multipack of 120. The clips were sold in a variety of colors and patterns and measure about 1.2 inches. The FNSKU number "X00RCTBRH" and "Made in China" are printed on a white label located on the plastic container box the clips are stored in.
Moderate
CPSCMay 1, 2025Nationwide• YuanQuXianXianQiDianZiShangWuYouXianZeRenGongSi, (dba YFLGOTOO), of China

Adult Manual Resuscitator (SunMed) – Filter Port Misplacement (2025)
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Very High
FDAMay 1, 2025Nationwide• SunMed Holdings, LLC

Azure S DR MRI SureScan (Medtronic) – Battery Failure Risk (2025)
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
Moderate
FDAApr 29, 2025Nationwide• Medtronic, Inc.

Cadillac Escalade ESV (Cadillac) – Engine Hard Parts Issue (2025)
General Motors LLC (GM) is recalling certain 2021-2024 Cadillac Escalade and Escalade ESV, Chevrolet Silverado 1500, Suburban, and Tahoe, GMC Sierra 1500, Yukon, and Yukon XL vehicles equipped with a 6.2L V8 gas engine. The connecting rod and/or crankshaft engine components may have manufacturing defects that can lead to engine damage and engine failure.
Moderate
NHTSAApr 24, 2025Nationwide• CADILLAC

iBOT Personal Mobility Device (Mobius) – Balance Mode Risk (2025)
Software issue that could potentially lead to the device tipping over from Balance Mode.
Moderate
FDAApr 24, 2025Nationwide• Mobius Mobility LLC

Precision Sampling Set (Capnia) – Contamination Risk (2025)
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
Moderate
FDAApr 21, 2025Nationwide• Capnia Inc

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
Moderate
FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

Peeled Mango Pickle (Advance Food) – elevated lead levels (2025)
Product contains elevated levels of lead (0.0649 mg/kg)
Class IIModerate
FDAApr 16, 2025CT, MD, MA +3 more• Advance Food International Inc.

CADD-Solis VIP Pump (Smiths Medical) – Occlusion Alarm (2025)
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Very High
FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Very High
FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Very High
FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

REMISOL Advance Software (Beckman Coulter) – Date Processing (2025)
Laceration Risk
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
Moderate
FDAApr 8, 2025Nationwide• Beckman Coulter Inc.

Brilliance CT Big Bore (Philips) – Gantry Motion Risk (2025)
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Moderate
FDAApr 1, 2025Nationwide• Philips North America Llc

3.0 Liter Disposable Set (Belmont) – Connector Crack Risk (2025)
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Moderate
FDAMar 31, 2025Nationwide• Belmont Instrument LLC

Inflow/Bifurcated Outflow Line Kit (Belmont) – Connector Crack Risk (2025)
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Moderate
FDAMar 31, 2025Nationwide• Belmont Instrument LLC