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Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Jul 29, 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.

Cardinal Health 200, LLC is recalling 846 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination.

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

This notice was issued by FDA on September 15, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.", distributed us nationwide distribution.. 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.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, medical-devices.

What Happened

Cardinal Health 200, LLC initiated a voluntary recall of Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The trays may contain wipes potentially contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur, including irritation, erythema, or mild inflammation.

Which Products Are Affected

The recall affects 846 units distributed nationwide in the United States. Affected products include 32 catalog numbers and lot combinations such as:

  • KIT, GYN ROBOTIC GSAM (PBCCGRSGD, Lot NGKU0957)
  • KIT, GYN ROBOT ACCESSORY (PB35GYBJC, Lot NGKU2052)
  • KIT, PRIMARY RESECTION (PGVMOTBB19, Lot NGKT2394)
  • KIT, LIVER TRANSPLANT SUPPORT (PGVM07C26, Lot NGKT2394; PGVM07C27, Lot NGKT2394)
  • KIT, LIVER TRANSPLANT SUPPORT (PGV2LTNHN, Lots NGKV2390, NGKV3390)
  • KIT,UMMC GENERAL MAJOR TRANSPL (PG15OT92A, Lot NGKW2883)
  • KIT,MAJOR LITHOTOMY NEW HAN (PG23MLNLD, Lot NGKU3969)
  • KIT, GENDER CARE (PG29GCPCK, PG29GCPC3, Lot NGKU4716)
  • KIT, MUH LIVER (PG33LVMNC, Lot NGKU1994)
  • KIT, MIS HERNIA (PG35HPBJK, Lots NGKU0856, NGKU0957, NGKU2052)
  • KIT, GENERAL MAJOR (PG43MJEJD, Lot NGKW2883)
  • KIT, OPEN THORACOTOMY CMC (PVCGOTACF, Lot NGKV3487)
  • KIT, MER THORACOTOMY ABDOMINAL (PVX4TAMYB, PVX4TAMYC, Lot NGKU4716)
  • KIT, HEART II (PV23HEVAE, Lot NGKT2391)
  • KIT, FLAP ACCESSORY (PW35FABJE, Lot NGKT2394)
  • HMC ROBOTIC PACK (SBA23RBHNG, SBA23RBHNH, Lot NGKU0129)

Each product has associated UDI-DI numbers listed in the recall notice. Recall number Z-3095-2026. Classification: Class II.

What You Should Do

Consumers and healthcare facilities should follow guidance from the recalling firm regarding the affected products.

Why This Matters

Use of the potentially contaminated wipes could result in localized skin irritation, erythema, or mild inflammation in patients.

Source

FDA recall Z-3095-2026, Cardinal Health 200, LLC, Waukegan, IL.

Original source: FDA Official Notice ↗

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Elsewhere in the country: similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Similar body length

Nearest notices by article body length (1,983 characters here).

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Similar severity timing

Same severity (medium) notices issued closest in time to September 15, 2026.

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Questions & Answers

Common questions about this FDA recall.

What is this FDA recall about? ▾
Cardinal Health 200, LLC is recalling 846 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination.
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 "The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation." 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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