Drug & Device Safety Atlas
Class II FDA device recall · Z-2226-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624

Why it was recalled

Due to stain present on the surface of affected foley catheters.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444  33418 / 00801741019999 10801741019996 Lot Number: NGKW2813  33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015  33422 / 00801741020018 10801741020015 Lot Number: NGKW3707  33424 / 00801741020025 10801741020022 Lot Number: NGKW2669   Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897  33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771  33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029  33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689  33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441  33624 / 00801741020100 10801741020107 Lot Numbers: NGKQ1722 NGKQ3862 NGKT3259 NGKX0456

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI O.U.S.: Canada

Recall record

Recalling firm
C.R. Bard Inc
Product type
Devices
Recall number
Z-2226-2026
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Covington, GA
Recall initiated
2026-04-23

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2226-2026 · Source: openFDA enforcement.