Ultra Pure Non-Woven Sponges (Steris) – distribution problem (2022)
Product not approved for US distribution may have unknown quality characteristics.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Steris Corporation
Lot Codes / Batch Numbers
Lot Number: 202108
Products Sold
Lot Number: 202108
Steris Corporation is recalling 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 due to Product not approved for release for US distribution. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product not approved for release for US distribution
Recommended Action
Per FDA guidance
Crosstex notified accounts by Urgent Medical Device Recall letter dated 3/22/22 via email. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect on-hand inventory for Ultra Pure Non-Woven Sponges, lot #202108 (part numbers ENC100 and ENC4100). 2. Please reply via email or complete the Recall Response Form included with this Notification Letter and return to cvalderrama@hu-friedy.com. Crosstex will provide instructions for returning the affected product to us. 3. Identify and notify all Customers who you have further distributed the affected product. Impacted Customers shall be provided with a copy of this letter and Recall Response Form. 4. Your Customer s Recall Response Forms shall be collected and reconciled to your distribution records to ensure all affected product is accounted for. 5. Crosstex will coordinate return of the product and credit issuance upon receipt of the completed Recall Response Form. If you have questions regarding this matter, please contact me at 312-579-9258.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026