Official recall notice

FDA DeviceClass IINotable

FDA Recall: CRE Wireguided 8-10mm 240cm

Recall date
2026-07-08
FDA class
Class II

Why it was recalled

Hazard

Potential sterile breach of the pouches in which devices are packaged.

Product description

Potential sterile breach of the pouches in which devices are packaged.

Affected products

UPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675; Exp. October 27, 2028 January 31, 2029.

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