The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1159-2021·Announced 2021-03-10

ReNovo Recalls Reprocessed Medical Devices Shipped as Sterile

ReNovo, Inc. is recalling 81 units of reprocessed medical devices that were shipped to customers labeled as sterile but were non-sterile.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as infection from non-sterile devices) are rated as Severe (4).

Plain-English summary

ReNovo, Inc. is recalling 81 units of various reprocessed medical devices, including Smith and Nephew Arthroscopic Shavers, Depy Mitek Ablation Electrodes, and Smith and Nephew Trocars/Cannulas. The recall was initiated because non-sterile products were shipped to customers with labels indicating they were sterile.

The affected products were distributed nationwide in California, New Jersey, and Oregon. Specific lot numbers involved in the recall include L-008926-16037, L-008918-16048, L-008918-16045, L-008936-16275, and L-008933-16078.

Healthcare facilities and customers who received these products should stop using them immediately and contact ReNovo, Inc. for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed…
Manufacturer
ReNovo, Inc.
Category
Medical Device — Reprocessed Surgical Instruments
Hazard
Affected units
81

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Number L-008926-16037 Lot numbers L-008918-16048
  • and L-008918-16045 Lot numbers L-008936-16275
  • and L-008933-16078

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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