Recall Z-0155-2027 ยท FEB Accessories, Cleaning, For Endoscope
Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
| Date | Oct 14, 2026 (initiated Sep 21, 2026) |
| Status | Open, Classified |
| 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 |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 9/8/26 was sent to customers. User Action Users can continue using the RAPICIDE product through the remainder of its shelf life. Please immediately inspect your on-hand inventory for product affected by this recall. If bottle bulging is observed, follow the instructions below to release any accumulated pressure and dispose of the product: 1. Users MUST wear personal protective equipment (PPE) before handling the bottle, including: a. Safety eyewear b. Chemical-resistant gloves c. A solvent-resistant apron d. Protective footwear appro |
| Quantity | 11806 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT Medivators Reprocessing Systems, Feb 13, 2009 |