BioFlo DuraMax Catheter — Class I medical device recall Z-1579-2026

Ongoing recall by Merit Medical Systems, Inc., reported 2026-04-01, distributed nationwide. 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may resu

Recall number	`Z-1579-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Merit Medical Systems, Inc., South Jordan, UT, United States
Recall initiated	2026-02-13
Classified	2026-03-26
Reported by FDA	2026-04-01
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BG, BO, BR, BZ, CA, CH, CL, CO, CR, DE, DO, EC, ES, FR, GB, GR, GT, HK, HN, ID, IE, IQ, IR, IT, JO, JP, KY, LV, MX, MY, NI, NL, PA, PE, PL, QA, SA, SE, SK, SV, TH, VE, VN, ZA
Quantity	47,153
UPC / GTIN / UDI-DI	`00884450786215`, `00884450786253`, `00884450786314`, `00884450792353`, `00884450792360`, `00884450793206`, `00884450793213`, `00884450793220`, `00884450793237`, `00884450793244`, `00884450793251`, `00884450793268`, `00884450793282`, `00884450793299`, `00884450793305`, `00884450793312`, `00884450793329`, `00884450793336`, `00884450835326`, `00884450835333`, `00884450835340`, `00884450835371`, `00884450840733`, `00884450840740`, `00884450840757` and 2 more
Lot numbers	`I2870746`, `I2902661`, `I2902662`, `I2902665`, `I2908636`, `I2909607`, `I2909610`, `I2909613`, `I2909617`, `I2909618`, `I2909637`, `I2910257`, `I2910263`, `I2910264`, `I2910265`, `I2920337`, `I2922255`, `I2927199`, `I2928443`, `I2928445`, `I2929338`, `I2973185`, `I2973186`, `I2975804`, `I2975805`, `I2975817`, `I2979931`, `I2979932`, `I2979959`, `I2979960`, `I2980492`, `I2997999`, `I3002035`, `I3010126`, `I3015730`, `I3015731`, `I3015758`, `I3044847`, `I3049565`, `I306492` and 93 more
Model numbers	`H965103028011/A`, `H965103028021/A`, `H965103028021/EU`, `H965103028031/A`, `H965103028031/EU`, `H965103028041/A`, `H965103028041/EU`, `H965103028051/A`, `H965103028051/EU`, `H965103028061/A`, `H965103028061/EU`, `H965103028070/A`, `H965103028070/EU`, `H965103028080/A`, `H965103028080/EU`, `H965103028090/A`, `H965103028090/EU`, `H965103028161/A`, `H965103028181/A`, `H965103028191/A`, `H965103028191/EU`, `H965103028201/A`, `H965103028211/A`, `H965103028220/A`, `H965103028230/A` and 135 more

Product

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

Reason for recall

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

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-1579-2026. 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.