Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14...
FDA Device Recall #Z-3117-2026 - Class II, June 25, 2026
Recall Summary
| Recall Number | Z-3117-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 25, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard Inc |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 391720 units/kits |
Product Description
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿ 10801741183222 00801741183249 10801741183246 00801741183263¿ 10801741183260 00801741183270¿ 10801741183277 00801741183287¿ 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164¿ 10801741183161 00801741183171¿ 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Reason for Recall
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.
Lot / Code Information
SureStep Intermittent Catheter Tray INTP16 / 00801741183300¿ 10801741183307 Lot Numbers: NGKT3672 NGKU1467 NGKU3559 INTS14 / 00801741183218 10801741183215 Lot Numbers: NGKT2630 NGKT2687 NGKT3636 NGKT3673 NGKU0119 NGKU0134 NGKU1412 NGKU1439 NGKU1494 NGKU2451 NGKU2487 NGKU2510 INTS14C / 00801741183232 10801741183239 Lot Numbers: NGKT2660 NGKU0149 NGKU1468 INTS16 / 00801741183225 10801741183222 Lot Numbers: NGKT2688 NGKT3587 NGKU0135 NGKU2423 INTS16C / 00801741183249 10801741183246 Lot Numbers: NGKT2631 NGKU0120 NGKU1413 PEDINTS06 / 00801741183263¿ 10801741183260 Lot Number: NGKU2452 PEDINTS08 / 00801741183270 10801741183277 Lot Numbers: NGKT3637 NGKU0166 NGKU1495 PEDINTS10 / 00801741183287¿ 10801741183284 Lot Number: NGKT3674 Pre-amendment INTL14 / 00801741183164 10801741183161 Lot Numbers: NGKT3670 NGKU0132 NGKU1491 INTL15 / 00801741183171 10801741183178 Lot Numbers: NGKT2658 NGKT3584 NGKT3609 NGKU0116 NGKU0118 NGKU0133 NGKU0147 NGKU0163 NGKU1411 NGKU1436 NGKU1437 NGKU1465 NGKU1466 NGKU1492 NGKU2421 NGKU2449 NGKU2450 NGKU2485 NGKU2486 NGKU2508 NGKU2509 NGKU4598 NGKU4601 INTL16 / 00801741183188 10801741183185 Lot Number: NGKU3558 INTP14 / 00801741183294 10801741183291 Lot Numbers: NGKT2659 NGKT3585 NGKT3610 NGKT3635 NGKU0148 NGKU1438 NGKU3567
Other Recalls from C.R. Bard Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3116-2026 | Class II | Products that contain the Pericare Wipes: *Bar... | Jun 25, 2026 |
| Z-3115-2026 | Class II | Products that contain the Pericare Wipes: Bard... | Jun 25, 2026 |
| Z-3114-2026 | Class II | Products that contain the Pericare Wipes: Ba... | Jun 25, 2026 |
| Z-3118-2026 | Class II | Products that contain the Pericare Wipes: Sure... | Jun 25, 2026 |
| Z-3119-2026 | Class II | Products that contain the Pericare Wipes: (Cana... | Jun 25, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.