CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report
Presource Packs Containing CliniClean Pericare Wipes within recalled
Cardinal Health 200 is recalling Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3105-2026
- FDA event ID
- 99553
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2026
- FDA classified
- 3 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jul 2026 | Recall initiated by company | |
| 3 Sep 2026 | Classified by FDA | +36 days |
| 9 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390 ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 99553This product is part of a recall event; the main page for the event is Presource Packs Containing CliniClean Pericare Wipes within recalled.
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |