Bard Silastic Foley Catheter recallZ-2226-2026 · C.R. Bard Inc · initiated Apr 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from C.R. Bard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to stain present on the surface of affected foley catheters.
FDA root cause category: Material/Component Contamination
What the company is doing
On 04/23/2026, the firm sent via region courier services "URGENT Medical Device Recall" Letters informing customers that BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected silastic catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter. Customers are instructed to: 1. Immediately Discontinue Use 2. Please check all inventory locations within your institution for the Bard Silastic Foley Catheters listed in Attachment 2. 3. Immediately quarantine and destroy all devices within your facility s control per your facility s procedures. 4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction. 5. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit. 6. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit. For Questions: Product Use Inquiries - 1-800-555-7422 option #2 available 24hours/7 days per week Product Complaints, Technical Support - 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: [email protected]
Recall details
- Recall number
- Z-2226-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 23, 2026
- Posted by the FDA
- May 21, 2026
- Recalling firm
- C.R. Bard Inc
- Quantity
- 106,160
- Product code
- EZL
- FDA submissions
- K951103
- Distribution
- 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
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
11 devices in the FDA device registry whose identifier appears in the recall's code information.
- Bard® Silastic® Foley Catheter 33620C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall50 reports
- Bard® Silastic® Foley Catheter 33618C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall39 reports
- Bard® Silastic® Foley Catheter 33616C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall30 reports
- Bard® Silastic® Foley Catheter 33420C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall26 reports
- Bard® Silastic® Foley Catheter 33624C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall25 reports
- Bard® Silastic® Foley Catheter 33416C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall16 reports
- Bard® Silastic® Foley Catheter 33418C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall11 reports
- Bard® Silastic® Foley Catheter 33422C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall11 reports
- Bard® Silastic® Foley Catheter 33424C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Bard® Silastic® Foley Catheter 33622C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall7 reports
- Bard® Silastic® Foley Catheter 33614C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall6 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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