RecallRadar

FDA Device recall Z-0787-2021

Vis-U-All High Temperature Tubing 4"x100'. One roll per box

On 2021-01-13 the FDA classified a Class II recall of Vis-U-All High Temperature Tubing 4"x100'. One roll per box by Steris, citing purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouch and in some insta….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0787-2021
ClassificationClass II
Statusterminated
Initiated2020-12-02
Published2021-01-13
Last updated2026-09-13 11:56 UTC
CompanySteris
DistributionUS

Product

Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041

Reason

Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Identifiers

code_infoLot Number: 200406A

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0787-2021%22

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