Disposable Light Handle Cover — Class II medical device recall Z-0523-2018
Terminated recall by Ecolab, Inc., reported 2018-02-14, distributed in MI. Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
| Recall number | Z-0523-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecolab, Inc., Saint Paul, MN, United States |
| Recall initiated | 2017-10-13 |
| Classified | 2018-02-05 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-07-22 |
| Distributed | MI |
| Quantity | 5,958 cases |
| Reason classes | sterility, packaging |
| Lot numbers | 14224, 14225, 14226, 14237, 14238, 14239, 14240, 14252, 14253, 14254, 14255, 14258, 14260, 14261, 14262, 14265, 14266, 14269, 14272, 14273, 14274, 14275, 14276, 14279, 14280, 14281, 14282, 14283, 14286, 14287, 14288, 14289, 14307, 14308, 14309, 14310, 14311, 14335, 14336, 14337 and 236 more |
| Model numbers | B1-715-65 |
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.
Reason for recall
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0523-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.