Products that contain the Pericare Wipes: *Bardex¿ I — Class II medical device recall Z-3116-2026
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-3116-2026 |
|---|---|
| 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 | 212,580 |
| UPC / GTIN / UDI-DI | 00801741024252, 00801741024269, 00801741024276, 00801741024344, 00801741073724, 00801741073731, 00801741073748, 00801741073755, 00801741073786, 00801741073793, 00801741073809, 00801741073816, 00801741073854, 00801741073861, 00801741073878, 00801741096600, 00801741100307, 00801741100314, 00801741100376, 00801741104206, 00801741104268, 00801741104299, 00801741104657, 00801741143243, 10801741024259 and 22 more |
| Lot numbers | 303316A, 303318A, A300314AC, A303316A, A303318A, A304714A, A304716A, A304718A, NGKS1605, NGKT2390, NGKT2410, NGKT2411, NGKT2448, NGKT2493, NGKT2496, NGKT3221, NGKT3222, NGKT3223, NGKT3224, NGKT3225, NGKT3288, NGKT3301, NGKT3315, NGKT3319, NGKT3392, NGKT3657, NGKU0894, NGKU0947, NGKU0951, NGKU0966, NGKU0973, NGKU0977, NGKU1020, NGKU1021, NGKU1022, NGKU1748, NGKU1826, NGKU1830, NGKU1833, NGKU2020 and 30 more |
| Model numbers | 300316A, 303314A, 303316A, 303318A, A300314A, A300314AC, A300316A, A300318A, A300414A, A303314A, A303316A, A303318A, A303414A, A304714A, A304716A, A304718A, A319414AM, A319416A, A319416AM, A319418A, A319418AM, A903316A, A903318A |
Product
Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿ 10801741024259 00801741024269 10801741024266 00801741024276¿ 10801741024273 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314A UDI codes: 00801741073724¿ 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300318A UDI code: 00801741073748¿ 10801741073745 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A303314A A303316A A303318A UDI code: 00801741073786¿ 10801741073783 00801741073793¿ 10801741073790 00801741073809¿ 10801741073806 *SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303414A UDI code: 00801741073816¿ 10801741073813 *(416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206¿ 10801741104203 00801741104268 10801741104265 00801741104299¿ 10801741104296 00801741100376¿ 10801741100373 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319416A UDI code: 00801741100307¿ 10801741100304 *SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861¿ 10801741073868 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319418A UDI code: 00801741100314¿ 10801741100311 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A903316A UDI code: 00801741096600¿ 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 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-3116-2026. 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.