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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97985

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 06, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
C.R. Bard 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

4 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 4

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Z-0905-2026
Recall number
Z-0905-2026
Initiated
November 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
C.R. Bard Inc
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

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

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Code information

Lot# NGJU4163/UDI: (01)00801741015403

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).

device · product 2 of 4

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

Z-0906-2026
Recall number
Z-0906-2026
Initiated
November 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
C.R. Bard Inc
Quantity
4350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

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

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Code information

Lot# NGJU4181/UDI: (01)00801741015687

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).

device · product 3 of 4

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

Z-0907-2026
Recall number
Z-0907-2026
Initiated
November 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
C.R. Bard Inc
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

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

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Code information

Lot# NGJU4327/UDI:(01)00801741015786

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).

device · product 4 of 4

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

Z-0908-2026
Recall number
Z-0908-2026
Initiated
November 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
C.R. Bard Inc
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

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

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Code information

Lot# NGJU4328/UDI: (01)00801741015922

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).