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Flexiva Pulse 242 Single-Use Laser Fibers-intended to be ... (Boston Scientific Corporation) – burn hazard (2023)

Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

Moderate

FDAMay 25, 2023Nationwide• Boston Scientific Corporation

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregi... (Philips Respironics, Inc.) – there are errors present in the korea... (2023)

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

Low

FDAMay 25, 2023Nationwide

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Flexiva Pulse 242 Single-Use Laser Fibers-intended to be ... (Boston Scientific Corporation) – burn hazard (2023)

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregi... (Philips Respironics, Inc.) – there are errors present in the korea... (2023)

Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Tropo... (QUIDEL CARDIOVASCULAR INC) – raw material issue may cause cardiac ... (2023)

2024 IC BUS CESB – navistar, inc (2023)

Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be... (Boston Scientific Corporation) – burn hazard (2023)

Janod Sweet Cocoon Activity Tables – Choking Risk (2023)

Math 1 and Math 3 Boxes – Laceration Hazard (2023)

2023 NISSAN ROGUE – nissan north america, inc (2023)

2019 JAGUAR I-PACE – fire hazard (2023)

2023 FONTAINE CONTAINER TRAILER – fontaine trailer company (fontaine tr... (2023)

2024 INTERNATIONAL LONESTAR – navistar, inc (2023)

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - inten... (Boston Scientific Corporation) – burn hazard (2023)

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT r... (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

2022 AUTOCAR LEGEND – autocar, llc (autocar) is recalling c... (2023)

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/n... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Endotracheal Tube oral/nasal Magill, High Volume, Low Pre... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

EliA GBM Wells, Material Number 14551401, for Phadia 250,... (Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden) – complaints that specific samples prod... (2023)

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)