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StealthStation S8 (Medtronic) – Surgical Data Shift (2023)

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

High

FDASep 27, 2023Nationwide• Medtronic Navigation, Inc.

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Moderate

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

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StealthStation S8 (Medtronic) – Surgical Data Shift (2023)

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

AMO Administration Set (B. Braun) – Potential Leakage Risk (2023)

Allergan Universal Fill Kit (B. Braun) – Potential Leakage Risk (2023)

SENTIERO Screening2 (PATH) – Technical Distortion (2023)

Burette Assembly (B. Braun) – Potential Leakage Risk (2023)

TheraSphere Admin Set (B. Braun) – Potential Leakage Risk (2023)

Large Bore Male Fitting (B. Braun) – Potential Leakage Risk (2023)

2-Port Burette Assembly (B. Braun) – Potential Leakage Risk (2023)

Fluid Transfer Set (B. Braun) – Potential Leakage Risk (2023)

RapidPoint 500 System (Siemens) – Drug Interference Risk (2023)

Grafton DMB Matrix (Medtronic) – Packaging Inspection Issue (2023)

Grafton DBM Crunch (Medtronic) – Packaging Inspection Issue (2023)

SENTIERO Medical Device (PATH) – Technical Distortion (2023)

RapidPoint 500e System (Siemens) – Drug Interference Risk (2023)

Terumo Tube Set (B. Braun) – Potential Leakage Risk (2023)

Grafton DBM Putty (Medtronic) – Packaging Inspection Issue (2023)

Grafton DBM Flex (Medtronic) – Packaging Inspection Issue (2023)

Angiographic Catheter Sets (Cordis) – Non-Sterile Distribution (2023)

SENTIERO Screening (PATH) – Technical Distortion (2023)