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TheraHoney Gel (Medline) – Sterilization Issue (2023)

Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.

Moderate

FDAMay 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Legacy SmartBase (Implant Direct) – FDA Clearance (2023)

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Moderate

FDAMay 2, 2023Nationwide• Implant Direct Sybron Manufacturing LLC

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TheraHoney Gel (Medline) – Sterilization Issue (2023)

Legacy SmartBase (Implant Direct) – FDA Clearance (2023)

Sertera Biopsy Device (Hologic) – Needle Detachment (2023)

Serrated Blade Applicator Kit (Helena) – Packaging Mismatch (2023)

ENGAGE Knee System (Smith & Nephew) – High Revision Rate (2023)

V-Sign Sensor 2 (SenTec) – Calibration Failure (2023)

Trilogy Evo O2/LifeVent (Philips) – Sensor Debris (2023)

Trilogy Evo O2 EV300 (Philips) – Sensor Debris (2023)

Veritor SARS-CoV-2/Flu Test (BD) – IFU Approval (2023)

Trilogy Evo Ventilator (Philips) – Sensor Debris (2023)

Trilogy Evo Universal Ventilator (Philips) – Ventilation Issue (2023)

Phadia 2500EE Instrument (Phadia) – Result Variation (2023)

EliA GliadinDP IgG Well (Phadia) – Result Variation (2023)

QIAstat-Dx Respiratory Panel (Qiagen) – False Test Results (2023)

HORIZON Microclip (Teleflex) – Clip Cartridge Issue (2023)

Intelli-C Right Tabletop (NRT X-Ray) – Drive Shaft Risk (2023)

Intelli-C Left Tabletop (NRT X-Ray) – Drive Shaft Risk (2023)

HeartSine Defibrillator (HeartSine) – Battery Failure (2023)

Incisive CT China (Philips) – Mounting Box Risk (2023)

Incisive CT Brazil (Philips) – Mounting Box Risk (2023)