CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" Product recalled
Cardinal Health 200 is recalling Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" Product, distributed nationwide in the US. The recall was initiated on 27 Dec 2018 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-0957-2019
- FDA event ID
- 82008
- Recalling firm
- Cardinal Health 200, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2018
- FDA classified
- 26 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 27 Dec 2018 | Recall initiated by company | |
| 26 Feb 2019 | Classified by FDA | +61 days |
| 6 Mar 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Curity All Purpose Sponges were not sterilized and distributed
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.
Where it was distributed
Worldwide distribution - US Nationwide and countries of Canada, Colombia.
Questions about this recall
Is Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" Product recalled?
Yes. Cardinal Health 200 recalled Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" Product on 27 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0957-2019.
Why was it recalled?
Curity All Purpose Sponges were not sterilized and distributed
Which lots are affected?
Lot Number: 18E190262 Expiration Date: 05/2023
Where was it sold?
Worldwide distribution - US Nationwide and countries of Canada, Colombia.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardinal Health 200
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|---|---|---|---|---|---|
| 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 |
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