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Manuka Honey + Reishi (Comvita) – Seal Leak (2025)

Leaking induction seal on packaging.

FDAMay 23, 2025AZ, CA, CO +5 more• COMVITA USA INC

Femoral Nail T2 GTN (Stryker) – Incorrect Nail Version (2025)

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

Moderate

FDAMay 22, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

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Manuka Honey + Reishi (Comvita) – Seal Leak (2025)

Femoral Nail T2 GTN (Stryker) – Incorrect Nail Version (2025)

Jewel Precision Sterilization Container (Jewel Precision) – Use Instructions Mismatch (2025)

Atellica CH Diluent (Siemens) – Contamination Risk (2025)

Extended Tip Applicator 8CM (Integra) – Endotoxin Concern (2025)

Change Healthcare Cardiology Software (Change Healthcare) – Unexpected Shutdown (2025)

Zoox Automated Driving System (Zoox) – Software Safety Issue (2025)

Nezmdi Baby Swings – Suffocation Risk (2025)

Rolanstar 6-Drawer Dressers (Areson) – tip-over risk (2025)

DTR Plush Bag Stitch and Angel (Primark) – choking risk (2025)

Sivan Six-Drawer Double Dressers – tip-over hazard (2025)

Holiday Lane Infant Pajamas – Injury Hazard (2025)

Acetaminophen Tablets (Aurobindo) - Tablet Discoloration (2025)

IontoPatch STAT (LTS Therapy) – Absorption Problem (2025)

Extended Tip Applicator 15CM (Integra) – Endotoxin Concern (2025)

IontoPatch 80 (LTS Therapy) – Absorption Problem (2025)

Femoral Nail T2 GTN (Stryker) – Incorrect Nail Version (2025)

Utilimaster Velocity (Utilimaster) – Missing Tire Placard (2025)

BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)

LUCAS Chest Compression System (Jolife) – Demonstration Unit Risk (2025)