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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91328

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

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Event summary

Timeline bucket
December 08, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Navigation, 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

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Z-0953-2023
Recall number
Z-0953-2023
Initiated
December 08, 2022
Classification
Class II
Status
Ongoing
Quantity
2317

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contamination, which can lead
Labeling or packaging reason.labeling_packaging · v1.0.0
pouch seal, incomplete
Sterility assurance reason.sterility_assurance · v1.0.0
sterile pouch seal, incomplete

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Code information

UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Distribution pattern

US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.