Device recall
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
- Recall number
- Z-0155-2027
- Event id
- 99804
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Steris Corporation
- Report date
- Oct 21, 2026
- Posted
- Oct 14, 2026
- Initiated
- Sep 21, 2026
- Center classification date
- Oct 14, 2026
- Product code
- FEB
- Device type
- Accessories, Cleaning, For Endoscope
- Reason
- If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- Root cause
- Process change control
- Quantity
- 11806 units
- Code info
- UDI: 00724995245955 Lot numbers with expiration dates: 689171 5/4/2027 689981 5/12/2027 690993 5/26/2027 691739 6/2/2027 692570 6/11/2027 694357 7/1/2027
- Distribution
- Worldwide - US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K082988
- Location
- Mentor, OH, United States