Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors
Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a labeling error due to unvalidated models rather than a direct safety hazard like contamination or malfunction. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Steris Corporation is recalling 64 units of the QKC1692E Quick Connect device. This device is used to connect endoscopes to the sterilization tray for the C1220E liquid chemical sterilization processor. The recall is being conducted to correct labeling errors.
The recall was initiated because Steris was unable to obtain two specific devices needed for revalidation projects. These two devices represent the design of seven models in one quick connect. Due to the unavailability of these validation devices, Steris is removing these seven models from the labeling of the QKC1692E and will re-label all QKC1692Es in the field.
The affected units were distributed nationwide in the United States, including in the states of AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV. The affected lot numbers are 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, and 3094190. Users should check their devices against these lot numbers and contact Steris Corporation for re-labeling instructions.
The recalled product
- Product
- QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 64
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 (9)
- Lot numbers: 1879717
- 1943786
- 2054914
- 2143717
- 2177723
- 2342319
- 2730752
- 2922565
- 3094190
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 Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
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
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSteris Quick Connects Recalled Due to Hysteroscope Port Mismatch
FDA (Devices) · 2016-03-23
- LowSTERIS Recalls Quick Connects for Labeling Updates
FDA (Devices) · 2013-07-03
- SevereSteris SYSTEM 1E Liquid Sterilant System Recalled for Hose Disconnection
FDA (Devices) · 2012-09-19
- ModerateSteris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues
FDA (Devices) · 2014-01-08
- LowSteris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error
FDA (Devices) · 2014-03-19
- HighSteris Reliance Endoscope Processing System Recalled for Air Pipe Defect
FDA (Devices) · 2013-10-02