FDA issued a warning letter for reprocessed medical devices: Renovo

Renovo specializes in reprocessing and cleaning medical devices like Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. While holding multiple 510(k) clearances, the FDA flagged issues regarding Renovo reprocessing models beyond their clearances. Specifically, reprocessing Arthrocare Ablation Wands, the FDA noted smaller dimensions, making cleaning and sterilization more challenging.

The warning letter addressed five 510(k) clearances, citing Renovo's addition of non-cleared models without assessing their impact on device performance. The FDA also noted breaches of good manufacturing practice, such as failing to set acceptable air particulate levels and assess potential issues with the air compressor system.

Renovo responded to air particulate testing concerns in June 2023, deemed adequate by the FDA. However, they will conduct a follow-up inspection to assess corrections.