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Showing 661–680 of 1734 results

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Atellica CH Protein Test (Siemens) – false result risk (2025)

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

FDAAug 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

FLEX Monoclonal Mouse Antibody (Agilent) – weak staining (2025)

Their is the potential for weak staining which may result in false negative CD20 identification.

FDAAug 11, 2025Nationwide• Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark

Continu-Flo Solution Set (Baxter) – customer reports (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

High

FDAAug 8, 2025Nationwide• Baxter Healthcare Corporation

IntelliSpace Cardiovascular (Philips) – outdated info (2025)

Software issue that results in the display of outdated information.

FDAAug 8, 2025Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Argus PB-3000 Monitor (Schiller) – measurement error (2025)

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

FDAAug 8, 2025Nationwide• Schiller, Ag Altgasse 68 Baar Switzerland

RayStation Software (RaySearch) – UID uniqueness (2025)

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

FDAAug 8, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Sterile Medline Convenience Kits (Unknown) – sterilization failure (2025)

Convenience kits labeled as sterile have not gone through the sterilization process.

FDAAug 8, 2025FL, MD, NJ +1 more

VACUETTE Coagulation Tube (Greiner) – label misplacement (2025)

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

FDAAug 8, 2025Nationwide• Greiner Bio-One North America, Inc.

FloPatch FP120 (Flosonics) – expiry date error (2025)

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

FDAAug 7, 2025Nationwide• Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada

Reef TA Inserter (SeaSpine) – implant engagement risk (2025)

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

FDAAug 6, 2025Nationwide• SEASPINE ORTHOPEDICS CORPORATION

CADD Medication Cassette (ICU Medical) – bag weld weakness (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

FDAAug 6, 2025Nationwide• ICU Medical Inc.

CADD Medication Cassette (ICU Medical) – bag weld issue (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

FDAAug 6, 2025Nationwide• ICU Medical Inc.

ViziShot 2FLEX Needle (Olympus) – tip deformity (2025)

Potential for undetected, deformed a-traumatic tips.

FDAAug 6, 2025Nationwide• Olympus Corporation of the Americas

DLP Left Heart Vent Catheter (Medtronic) – shape retention (2025)

The catheters may not retain their shape.

FDAAug 6, 2025Nationwide• Medtronic Perfusion Systems

Vasoview Hemopro 3 System (Maquet) – out-of-box failure (2025)

Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.

FDAAug 6, 2025Nationwide• Maquet Cardiovascular, LLC

Xpert SA Nasal Complete (Cepheid) – test result error (2025)

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

FDAAug 6, 2025Nationwide• Cepheid

NRFit CADD Medication Cassette (ICU Medical) – bag weld issue (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

FDAAug 6, 2025Nationwide• ICU Medical Inc.

MediHoney Paste (Integra) – packaging failure (2025)

Packaging failures were identified which could lead to a breach in the sterile barrier.

FDAAug 5, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Unity Accessory Devices (Alcon) – incomplete seal (2025)

Due to incomplete seals in the pouch which provide the sterile barrier.

FDAAug 5, 2025Nationwide• Alcon Research LLC

CVS Honey Pad (Integra) – packaging breach (2025)

Packaging failures were identified which could lead to a breach in the sterile barrier.

FDAAug 5, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

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