Official recall notice

FDA DeviceClass IINotable

FDA Recall: CRE Wireguided 6-8mm 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: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759; Exp. October 27, 2028 February 24, 2029.

Verify with the official notice →
Share:

Related Recalls

2026-09-09 · FDA_DEVICE
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model
Boston Scientific Corporation
2026-09-09 · FDA_DEVICE
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model
Boston Scientific Corporation
2026-09-09 · FDA_DEVICE
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model
Boston Scientific Corporation
2026-08-26 · FDA_DEVICE
FDA Recall: Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation