Products that contain the Pericare Wipes: SureStep" Foley Tray System… — Class II medical device recall Z-3118-2026
Ongoing recall by C.R. Bard Inc, reported 2026-09-16, distributed nationwide. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with
| Recall number | Z-3118-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2026-06-25 |
| Classified | 2026-09-04 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, CA, CR, GT, MX, SA |
| Quantity | 33,850 units |
| UPC / GTIN / UDI-DI | 00801741073847, 00801741073915, 00801741074097, 00801741100369, 00801741121067, 00801741183317, 10801741073844, 10801741073912, 10801741074094, 10801741100366, 10801741121064, 10801741183314 |
| Lot numbers | NGKS2397, NGKT2456, NGKT3231, NGKT3292, NGKU0999, NGKU1023, NGKU1026, NGKU1409, NGKU2042, NGKU2051, NGKU3043 |
| Model numbers | A153200, A304400A, A399400, A399400A, A904400A |
Product
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Reason for recall
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3118-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.