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Showing 3861–3880 of 4465 results

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Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

Class IIILow

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES 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.

Moderate

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

Jayco Eagle HT Travel Trailer (Jayco) – Certification Label Issue (2025)

Jayco, Inc. (Jayco) is recalling certain 2025 Jayco Eagle fifth wheels, Eagle HT fifth wheels, and Eagle HT travel trailers. The certification label states incorrect tire load and tire size information. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."

High

NHTSAMar 4, 2025Nationwide• JAYCO TRAVEL TRAILER

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.

High

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

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.

Moderate

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.

Moderate

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.

Moderate

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

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.

Moderate

FDAMar 4, 2025Nationwide• Medtronic Neuromodulation

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.

Moderate

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

Triumph Speed Twin 900 (Triumph) – Turn Signal Defect (2025)

Triumph Motorcycles America, Ltd. (Triumph) is recalling certain 2025 Speed Twin 1200, Speed Twin 1200 RS, and Speed Twin 900 motorcycles. The red rear turn signals were installed too close to the rear tail light. As such, these motorcycles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, reflective devices, and associated Equipment."

High

NHTSAMar 4, 2025Nationwide• TRIUMPH

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

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

Moderate

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

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)

Moderate

FDAMar 3, 2025Nationwide• Tornier, Inc

Motiv F-59 BEV School Bus Chassis (Motiv) – Throttle Position Sensor Fault (2025)

Motiv Power Systems, Inc. (Motiv) is recalling certain 2017-2020 E-450 and F-59 school buses with Gen 4 EPIC powertrain, and 2020-2023 E-450, F-59, and F-53 school buses with a Gen 5 EPIC powertrain. A throttle position sensor (TPS) power wire connector pin may loosen, causing a loss of signal to the powertrain control module and a loss of drive power.

High

NHTSAMar 3, 2025Nationwide• MOTIV

Motiv F-53 Chassis (Motiv) – Throttle Position Sensor Fault (2025)

Motiv Power Systems, Inc. (Motiv) is recalling certain 2017-2020 E-450 and F-59 vehicles with Gen 4 EPIC powertrain, 2020-2023 E-450, F-59, and F-53 vehicles with a Gen 5 EPIC powertrain, and 2023-2025 Motiv F-59 and F-53 vehicles with a Gen 6 EPIC powertrain. A throttle position sensor (TPS) power wire connector pin may loosen, causing a loss of signal to the powertrain control module and a loss of drive power.

High

NHTSAMar 3, 2025Nationwide• MOTIV

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.

Moderate

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.

Low

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.

High

FDAMar 3, 2025Nationwide• Baxter Healthcare Corporation

CDI OneView Monitoring System (Terumo) – Display Value Issue (2025)

During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

Low

FDAMar 3, 2025FL, IL, MI +3 more• Terumo Cardiovascular Systems Corporation

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.

Low

FDAMar 3, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Carvedilol Tablets 6.25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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