Data Foundry

Medical device recalls 2026

Products that contain the Pericare Wipes: SureStep Intermittent… — Class II medical device recall Z-3117-2026

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 numberZ-3117-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmC.R. Bard Inc, Covington, GA, United States
Recall initiated2026-06-25
Classified2026-09-04
Reported by FDA2026-09-16
DistributedNationwide (US)
Countries outside the USAE, BH, CA, CR, GT, MX, SA
Quantity391,720 units
UPC / GTIN / UDI-DI00801741183164, 00801741183171, 00801741183188, 00801741183218, 00801741183225, 00801741183232, 00801741183249, 00801741183263, 00801741183270, 00801741183287, 00801741183294, 00801741183300, 10801741183161, 10801741183178, 10801741183185, 10801741183215, 10801741183222, 10801741183239, 10801741183246, 10801741183260, 10801741183277, 10801741183284, 10801741183291, 10801741183307
Lot numbersINTL14, INTL15, INTL16, INTP14, INTS14, INTS14C, INTS16, INTS16C, NGKT2630, NGKT2631, NGKT2658, NGKT2659, NGKT2660, NGKT2687, NGKT2688, NGKT3584, NGKT3585, NGKT3587, NGKT3609, NGKT3610, NGKT3635, NGKT3636, NGKT3637, NGKT3670, NGKT3672, NGKT3673, NGKT3674, NGKU0116, NGKU0118, NGKU0119, NGKU0120, NGKU0132, NGKU0133, NGKU0134, NGKU0135, NGKU0147, NGKU0148, NGKU0149, NGKU0163, NGKU0166 and 35 more
Model numbersINTL14, INTL15, INTL16, INTP14, INTP16, INTS14, INTS14C, INTS16, INTS16C, PEDINTS06, PEDINTS08, PEDINTS10

Product

Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿ 10801741183222 00801741183249 10801741183246 00801741183263¿ 10801741183260 00801741183270¿ 10801741183277 00801741183287¿ 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164¿ 10801741183161 00801741183171¿ 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 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-3117-2026. 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.