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STA R Max Instrument (Diagnostica Stago) – coagulation time issue (2023)

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Surgical Convenience Kits (ROi CPS) – light handle cover separation (2023)

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

FDAMar 22, 2023Nationwide• ROi CPS LLC

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STA R Max Instrument (Diagnostica Stago) – coagulation time issue (2023)

Surgical Convenience Kits (ROi CPS) – light handle cover separation (2023)

Alprazolam C-IV 1mg (Direct Rx) – Cross Contamination Risk (2023)

Alprazolam C-IV 0.5mg (Direct Rx) – Cross Contamination Risk (2023)

Alprazolam C-IV 2mg (Direct Rx) – Cross Contamination Risk (2023)

ASM Replacement Battery (ICU Medical) – early capacity loss (2023)

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

ARTIS One Angiography System (Siemens) – monitor display issue (2023)

Philips Azurion System (Philips) – X-ray functionality loss (2023)

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

Aesculap Caiman Articulating Device (Aesculap) – spring detachment risk (2023)

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

COBRA-OS Sheath Introducer (Merit Medical) – incorrect needle size (2023)

ExactaMed Oral Dispenser (Baxter) – particulate matter risk (2023)

Peterbilt 579 (Peterbilt) – parking brake valve issue (2023)

Meritor Front Drive Steer Axle (Meritor) – fastener risk (2023)

Infiniti QX50 (Infiniti) – incorrect door latch (2023)

Prevost H3-45 (Prevost) – emergency exit force issue (2023)

Kentucky Trailer XL-12 (Kentucky Trailer) – winch wireless fault (2023)