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Showing 1321–1340 of 1734 results

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Distal Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Tibial Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Enhanced Verify Handset (Medtronic) – Communication Malfunction (2025)

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

Moderate

FDAApr 3, 2025Nationwide• Medtronic Neuromodulation

Atalante X Exoskeleton (Wandercraft) – Balance Loss Risk (2025)

Potential for exoskeleton to lose lateral balance and cause patient to fall.

FDAApr 3, 2025NY, PA• WANDERCRAFT SAS

Posterior Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

MAGEC 2 Rod (Globus Medical) – Incorrect Rod Diameter (2025)

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

FDAApr 3, 2025Nationwide• Globus Medical, Inc.

L-Shaped Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Aquadis 56 Washer Disinfector (Getinge) – Circulation Pump Timing Error (2025)

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

FDAApr 2, 2025Nationwide• Getinge Disinfection Ab Ljungadalsgatan

HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)

There is a leakage issue associated with the tubing in the manifold of the instrument.

FDAApr 2, 2025AZ, CA, FL +11 more• Leica Biosystems Melbourne Pty Ltd

Biomet 3i Abutment (Preat) – Screw Seat Positioning Problem (2025)

Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

FDAApr 2, 2025Nationwide• Preat Corp

myQA iON (IBA Dosimetry) – Analysis Result Inaccuracy (2025)

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

FDAApr 1, 2025Nationwide• IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany

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.

FDAApr 1, 2025Nationwide• Philips North America Llc

Halyard CABG Suture Pack (AVID Medical) – Needle Coating Problem (2025)

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

FDAMar 31, 2025Nationwide• AVID Medical, Inc.

Inflow/Outflow Patient 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.

FDAMar 31, 2025Nationwide• Belmont Instrument 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.

FDAMar 31, 2025Nationwide• Belmont Instrument LLC

Halyard Rapides E-Pack (AVID Medical) – Needle Coating Problem (2025)

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

FDAMar 31, 2025Nationwide• AVID Medical, Inc.

Stratus CS Cardiac Troponin Test (Siemens) – Potential Test Issue (2025)

Laceration Risk

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

FDAMar 31, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Halyard Christ Suture Kit (AVID Medical) – Needle Coating Problem (2025)

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

FDAMar 31, 2025Nationwide• AVID Medical, Inc.

Triton Ultrasonic Cleaning Systems (Ultra Clean) – Sensor Degradation (2025)

During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

FDAMar 31, 2025Nationwide• Ultra Clean Systems, Inc.

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.

FDAMar 31, 2025Nationwide• Belmont Instrument LLC

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