CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report

BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled

C.R. Bard is recalling BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit, distributed nationwide in the US. The recall was initiated on 6 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# NGJU4328/UDI: (01)00801741015922

Quantity recalled116 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0908-2026
FDA event ID: 97985
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Nov 2025
FDA classified: 11 Dec 2025
Reported: 17 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

6 Nov 2025	Recall initiated by company
11 Dec 2025	Classified by FDA	+35 days
17 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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).

Nationwide Arizona California Colorado Florida Georgia Iowa Indiana Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Dakota New Jersey New York Ohio Pennsylvania South Dakota Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot# NGJU4328/UDI: (01)00801741015922

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97985

This product is part of a recall event; the main page for the event is BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled.

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025	CLASS II	BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled	C.R. Bard	Device Malfunction	Nationwide
17 Dec 2025	CLASS II	Bard InLay Optima Size:., Ureteral Stent Kit recalled by C.R. Bard	C.R. Bard	Device Malfunction	Nationwide
17 Dec 2025	CLASS II	BD InLay Optima Ureteral Stent Kit Size: 4.., Ureteral Stent Kit recalled	C.R. Bard	Device Malfunction	Nationwide

More recalls from C.R. Bard

All 123

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide

Other Heart & Vascular Devices recalls

All 6,212

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23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states