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ROTAWIRE Drive (Boston Scientific) – Sterility Compromise (2022)

Pouch seals may be open, compromising sterility.

FDAMar 8, 2022IN• Boston Scientific Corporation

EVIS EXERA Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

FDAMar 8, 2022Nationwide• Olympus Corporation of the Americas

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ROTAWIRE Drive (Boston Scientific) – Sterility Compromise (2022)

EVIS EXERA Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

EVIS EXERA Bronchofibervideoscope (Olympus) – Reprocessing Instructions (2022)

Mercedes-Benz Sprinter 4500 (Mercedes-Benz) – Suspension Shim Problem (2022)

Coachmen Freedom Express (Coachmen) – Trailer Equipment Risk (2022)

YSIO X.Pree (Siemens) – X-Ray Collimation Issue (2022)

Acuson 9vE4 Transducer (Siemens) – Thermal Index Limit Exceed (2022)

UBCO 2X2 ADV (UBCO) – Hub Motor Gear Risk (2022)

Siemens SOMATOM Scanner (Siemens) – Software Workflow Interruption (2022)

Yamaha MT-09 (Yamaha) – Engine Control Problem (2022)

Alprostadil/Papaverine/Phentolamine (Tailor Made Compounding) – Sterility Risk (2022)

Sermorelin/Glycine (Tailor Made) – Sterility Concern (2022)

Vitamin D3 (Tailor Made Compounding) – Sterility Risk (2022)

Methylcobalamin (Tailor Made) – Sterility Concern (2022)

GAC (Tailor Made) – Sterility Concern (2022)

Teriparatide (Tailor Made Compounding) – Sterility Risk (2022)

Vitamin B-Complex (Tailor Made) – Sterility Concern (2022)

Sermorelin/Glycine (Tailor Made) – Sterility Concern (2022)

Hydroxocobalamin Preservative Free (Tailor Made) – Sterility Concern (2022)

Pentosan Polysulfate Sodium (Tailor Made) – Sterility Concern (2022)