OVERLOOKED

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Class IIOngoing

C.R. Bard Inc recalls 6 products

Recall date · record updated Sep 16, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
C.R. Bard Inc
Reason
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98840…

Products (6)

  1. Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018 SureStep" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

    Codes/lots: Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 00801741024825¿ 10801741024822 Lot Number: NGKU3555 ***** SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley TQuantity: 12,463 trays/kitsRecall no. Z-3114-2026Class II

  2. Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300416A UDI code: 00801741073762¿ 10801741073769 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A307416A A307418A UDI codes: 00801741104381¿ 10801741104388 00801741100505¿ 10801741100502 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042¿ 10801741074049 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059¿ 10801741074056 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A907316 UDI code: 00801741104749¿ 10801741104746 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942210 UDI code: 00801741100567¿ 10801741100564 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942212 UDI code: 00801741100536¿ 10801741100533 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942214 UDI code: 00801741074103¿ 10801741074100 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696¿ 10801741024693 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670¿ 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A300916A UDI code: 00801741120862¿ 10801741120869 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A900916A UDI code: 00801741121029¿ 10801741121026 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763¿ 10801741104760 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley

    Codes/lots: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762¿ 10801741073769 Lot Numbers: NGKT3316 NGKU0946 NGKU0972 NGKU1747 NGKU1823 SureSQuantity: 283883 trays/kitsRecall no. Z-3115-2026Class II

  3. Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿ 10801741024259 00801741024269 10801741024266 00801741024276¿ 10801741024273 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314A UDI codes: 00801741073724¿ 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300318A UDI code: 00801741073748¿ 10801741073745 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A303314A A303316A A303318A UDI code: 00801741073786¿ 10801741073783 00801741073793¿ 10801741073790 00801741073809¿ 10801741073806 *SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303414A UDI code: 00801741073816¿ 10801741073813 *(416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206¿ 10801741104203 00801741104268 10801741104265 00801741104299¿ 10801741104296 00801741100376¿ 10801741100373 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319416A UDI code: 00801741100307¿ 10801741100304 *SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861¿ 10801741073868 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319418A UDI code: 00801741100314¿ 10801741100311 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A903316A UDI code: 00801741096600¿ 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

    Codes/lots: Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: **** SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316A / Quantity: 212580Recall no. Z-3116-2026Class II

  4. 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.

    Codes/lots: 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 / Quantity: 391720 units/kitsRecall no. Z-3117-2026Class II

  5. Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

    Codes/lots: SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A304400A / 00801741073847¿ 10801741073844 Lot Numbers: NGKU1023 NGKU3043 SureStep" Foley Tray System Add-A-Foley Catheter A399400 / 00801741100369¿ 10801741100366 Lot Number: NGKU2042 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A399400A / 00801741073915¿ 10801741073912 Lot Numbers: NGKT2456 NGKT3292 NGKU0999 NGKU1026 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A904400A / 00801741074Quantity: 33850 units/kitsRecall no. Z-3118-2026Class II

  6. Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011¿ SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

    Codes/lots: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316AC / 00801741143250 Lot Number: NGKU2005 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AMC / 00801741143472 Lot Number: NGKT2392 SureStep" Foley Tray System Bard¿ Lubricath Foley A800366C / 00801741143571 Lot Number: NGKT2413 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897514C / 00801741074011¿ Lot Number: NGKU0852 SureStep" Foley Tray System Bard¿ Silicone Foley CatQuantity: 364Recall no. Z-3119-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

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