CLASS II ONGOING Device recall · Reported 27 May 2026 · FDA Enforcement Report
Silastic Foley Catheters Silastic Foley Catheter 30cc recalled
C.R. Bard is recalling Silastic Foley Catheters Silastic Foley Catheter 30cc, distributed in 44 states. The recall was initiated on 23 Apr 2026 and the FDA has classified it as Class II.
Check your package
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-2226-2026
- FDA event ID
- 98716
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2026
- FDA classified
- 21 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Apr 2026 | Recall initiated by company | |
| 21 May 2026 | Classified by FDA | +28 days |
| 27 May 2026 | 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
Due to stain present on the surface of affected foley catheters.
Product as listed by the FDA
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
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
AlaskaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Is Silastic Foley Catheters Silastic Foley Catheter 30cc recalled?
Yes. C.R. Bard recalled Silastic Foley Catheters Silastic Foley Catheter 30cc on 23 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2226-2026.
Why was it recalled?
Due to stain present on the surface of affected foley catheters.
Which lots are affected?
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
Where was it sold?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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