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Showing 1441–1460 of 1734 results

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Venue Fit Models R3/R4 (GE Medical Systems) – Battery Fire Risk (2025)

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

ReNewal Coblator II ENT Evac Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

HoloBlueprint Application (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

Blueprint Mixed Reality (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

ReNewal Coblator II Plasma Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

ReNewal ENT Coblator II PROcise Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

FDAMar 5, 2025AZ, FL, MI +3 more• Advanced Bionics, LLC

ID NOW Influenza A/B Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

Stimulation RC Programmer (Medtronic) – Software Communication Fault (2025)

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

FDAMar 4, 2025Nationwide• Medtronic Neuromodulation

AutoPulse NXT Resuscitation System (ZOLL) – Compression Malfunction (2025)

AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

FDAMar 4, 2025AL, CA, CT +16 more• ZOLL Circulation, Inc.

Smart Control Vascular Stent System (Cordis) – Product Mix-Up (2025)

product mix-up; Vascular stent labeled as one size but contains a different size.

FDAMar 4, 2025AZ, AR, FL +2 more• Cordis US Corp

InPen Smart Insulin Pen (Medtronic) – Assembly Error (2025)

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

FDAMar 4, 2025AL, AZ, AR +38 more• Medtronic MiniMed, Inc.

ID NOW RSV Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW COVID-19 Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

Smart Control Vascular Stent System (Cordis) – Product Mix-Up (2025)

product mix-up; Vascular stent labeled as one size but contains a different size.

FDAMar 4, 2025AZ, AR, FL +2 more• Cordis US Corp

Medline Convenience Kits (Medline) – Packaging Seal Weakness (2025)

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

FDAMar 3, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

NovumIQ Syringe Infusion System (Baxter) – Incorrect Installation (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

FDAMar 3, 2025Nationwide• Baxter Healthcare Corporation

Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)

Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

FDAMar 3, 2025Nationwide• ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland

Medline Kits (Medline) – Packaging Seal Weakness (2025)

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

FDAMar 3, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Latitude EV Humeral Revision Stem (Stryker) – Incorrect Part Marking (2025)

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

FDAMar 3, 2025Nationwide• Tornier, Inc

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