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.
FDA Recall Z-3117-2026 · Posted 2026-09-04
Advertisement
Reason for Recall
Firm Action
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement