FDA-Device2022-06-01Class II
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Hazard
Product not approved for release for US distribution
Sold states
Nationwide
Affected count
152 cases
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2022More Steris Corporation recalls
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for detachable control buttons
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for paint delamination
- FDA-Device2026-06-24Steris ALYON Surgical Lighting System recalled for detachable control buttons
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