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C.R. Bard Foley Catheter Trays Recall Over Pericare Wipes Contamination (Jun 25, 2026)

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

C.R. Bard Inc. is recalling 212,580 units of various Bardex I.C. Complete Care Foley Catheter Trays and related systems due to contamination on the Pericare Wipes.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

C.R. Bard Inc. initiated a voluntary recall after receiving complaints about contamination on the surface of Pericare Wipes included with various Foley and Intermittent Catheter Trays. The recall is classified as Class II and remains ongoing.

Which Products Are Affected

The recall covers multiple products containing Pericare Wipes, including:

  • Bardex I.C. Complete Care Foley Catheter Tray REF 300316A (UDI: 00801741024344, 10801741024341), lot NGKT3657
  • Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter REFs 303314A, 303316A, 303318A (various UDIs), specific lots including NGKU4153, NGKW2883, NGKU0966
  • SureStep Foley Tray System Bardex IC Complete Care REFs A300314A, A300316A, A300318A, A303314A, A303316A, A303318A, A303414A, A304714A, A304716A, A304718A, A319416A, A319418A, A903316A, A903318A and related variants (various UDIs and numerous lot numbers listed in source)
  • SureStep Foley Tray System Lubri-Sil IC Complete Care REFs A300414A and others (various UDIs and lots)
  • SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter REFs A319414AM, A319416AM, A319418AM (various UDIs and lots) A total of 212,580 units are affected. Distribution was nationwide in the United States (including 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, WY) and to Bahrain, Canada, Costa Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates. All products are for urological use only.

What You Should Do

Consumers should follow instructions provided in the firm's notification letter regarding the affected products.

Why This Matters

The recall involves a large quantity of catheter trays distributed worldwide, addressing potential contamination risks in urological devices.

Source

FDA recall number Z-3116-2026; https://www.fda.gov

Original source: FDA Official Notice ↗

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Comparable nationwide notices (length or severity timing) 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Similar body length

Nearest notices by article body length (1,941 characters here).

Flood Warning Issued for Victoria River Catchment in Northern Territory 1,941 chars Major Flood Warning Issued for Daly River: Highest Levels Since 1998 Expected 1,941 chars Heavy Freezing Spray and Gale Warnings Issued for Lake Superior and Michigan Coastal Waters 1,941 chars Severe Thunderstorm Warning Issued for North Florida and South Georgia Through 12:45 PM 1,941 chars

Similar severity timing

Same severity (medium) notices issued closest in time to September 22, 2026.

Yellow Fog Advisory for Inuvik Region (Sep 22, 2026) medium Yellow Air Quality Warning for Ft. Simpson Region (Sep 22, 2026) medium Yellow Storm Surge Warning for Herschel Island, Yukon (Sep 22, 2026) medium M 5.1 Earthquake 88 km NNW of Uken, Japan medium

What People Ask

Common questions about this FDA recall.

What is this FDA recall about? ▾
C.R. Bard Inc. is recalling 212,580 units of various Bardex I.C. Complete Care Foley Catheter Trays and related systems due to contamination on the Pericare Wipes.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter? ▾
The FDA classifies this as a Class II recall, citing "Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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