CLASS II Device recall · Reported 1 Jun 2022 · FDA Enforcement Report
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5 25 sleeves recalled
Steris is recalling Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5 25 sleeves of 200 / x, distributed nationwide in the US. The recall was initiated on 22 Mar 2022 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-1118-2022
- FDA event ID
- 90050
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2022
- FDA classified
- 20 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Hidden Drug Ingredients
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2022 | Recall initiated by company | |
| 20 May 2022 | Classified by FDA | +59 days |
| 1 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product not approved for release for US distribution
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Product not approved for release for US distribution
Which lots are affected?
Lot Number: 202108
Where was it sold?
Nationwide
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
1 other product · FDA event 90050| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2 10 sleeves recalled | Steris | Hidden Drug Ingredients | Nationwide |
More recalls from Steris
All 120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Verify Biological Steam Test Pack recalled by Steris | Steris | Sterility | Nationwide |
| Device | CLASS II | HexaVue Focus Integration System, a single recalled by Steris | Steris | Device Malfunction | Nationwide |
| Device | CLASS II | Verify Biological/Integrator Challenge Pack recalled by Steris | Steris | Sterility | Nationwide |
| Device | CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
| Device | CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |