Class II — Ecolab, Inc.
| Recalling firm | Ecolab Inc |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| Product | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device. |
| Quantity | 5,958 cases (50 per case) |
| Distribution | Distributed domestically to Michigan. |
| Initiated | 2017-10-13 |
| Classified | 2018-02-05 |
| Terminated | 2020-07-22 |
| Recall number | Z-0523-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ecolab, Inc. (Z-0523-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78419/
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