Medium RiskFDA Device

Steris Corporation: 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; 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 devi

Agency Publication Date: January 21, 2021

Affected Products

Product: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713

Lot Number: 200425A, 200625A

Lot Numbers:

Number

Product: Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039

Lot Number: 200428A, 200628A

Lot Numbers:

Number

Product: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118

Lot Number: 200430A

Lot Numbers:

Number

Product: Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411

Lot Number: 200434A

Lot Numbers:

Number

Product: Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510

Lot Number: 200435A, 200635A

Lot Numbers:

Number

Product: Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515

Lot Number: 200536A

Lot Numbers:

Number

Product: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713

Lot Number: 200437A, 200637A

Lot Numbers:

Number

Product: Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816

Lot Number: 200438A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061

Lot Number: 200407A, 200707A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091

Lot Number: 200408A

Lot Numbers:

Number

Product: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411

Lot Number: 200421A, 200521A

Lot Numbers:

Number

Product: Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

Lot Number: 200424A, 200524A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031

Lot Number: 200505A

Lot Numbers:

Number

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

Lot Number: 200406A

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86942

Status: Resolved

Manufacturer: Steris Corporation

Manufactured In: United States

Units Affected: 14 products (7 cases; 65 units; 98 cases; 197 cases; 53 cases; 54 cases; 31 cases; 170 cases; 589 cases; 43 cases; 229 cases; 7 cases; 201 cases; 46 cases)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713

Lot Number: 200425A, 200625A

Lot Numbers:

Number

Product: Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039

Lot Number: 200428A, 200628A

Lot Numbers:

Number

Product: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118

Lot Number: 200430A

Lot Numbers:

Number

Product: Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411

Lot Number: 200434A

Lot Numbers:

Number

Product: Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510

Lot Number: 200435A, 200635A

Lot Numbers:

Number

Product: Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515

Lot Number: 200536A

Lot Numbers:

Number

Product: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713

Lot Number: 200437A, 200637A

Lot Numbers:

Number

Product: Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816

Lot Number: 200438A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061

Lot Number: 200407A, 200707A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091

Lot Number: 200408A

Lot Numbers:

Number

Product: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411

Lot Number: 200421A, 200521A

Lot Numbers:

Number

Product: Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

Lot Number: 200424A, 200524A

Lot Numbers:

Number

Product: Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031

Lot Number: 200505A

Lot Numbers:

Number

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

Lot Number: 200406A

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86942

Status: Resolved

Manufacturer: Steris Corporation

Manufactured In: United States

Units Affected: 14 products (7 cases; 65 units; 98 cases; 197 cases; 53 cases; 54 cases; 31 cases; 170 cases; 589 cases; 43 cases; 229 cases; 7 cases; 201 cases; 46 cases)