Exact FDA event identifier

Event 87258

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 19, 2021
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ReNovo, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

Z-1159-2021

Recall number: Z-1159-2021
Initiated: January 19, 2021
Classification: Class II
Status: Ongoing
Recalling firm: ReNovo, Inc.
Quantity: 81 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Non-sterile product was shipped to customers labelled as sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-sterile product was shipped to customers labelled as sterile.

Code information

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

Distribution pattern

US Nationwide distribution in the states of CA, NJ and OR.