Steris recalls 77 packs of medical tubing due to failed process indicators
Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which by definition indicates the product is unlikely to cause adverse health consequences. The source text does not report any injuries or illnesses.
Plain-English summary
Steris Corporation is recalling 77 packs of 100-foot rolls of medical tubing. The product is distributed in cardboard boxes and is used to seal medical devices prior to ethylene oxide sterilization, maintaining their sterility until opened.
The recall was initiated after the firm became aware on July 20, 2012, that a lot of tubing was distributed by the supplier after it had been rejected by Steris due to failing process indicators. The specific product code is KCT and the lot number is 60263.
The affected products were distributed worldwide, including nationwide in the United States and in Japan, Peru, and Suriname. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 77
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product code KCT
- Lot number: 60263
Distribution
Related recalls
Same manufacturer · Steris Corporation
See all →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateSteris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration
FDA (Devices) · 2018-03-07
- ModerateSTERIS Sterilization Indicators Recalled Due to Temperature Excursions
FDA (Devices) · 2022-10-05
- LowSteris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error
FDA (Devices) · 2014-03-19
- LowSteris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
FDA (Devices) · 2018-03-07
- ModerateSteris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators
FDA (Devices) · 2022-09-21
- ModerateSteris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues
FDA (Devices) · 2014-01-08