Laparoscopy CDS — Class II medical device recall Z-2978-2018
Terminated recall by Medline Industries, Inc., reported 2018-09-12, distributed in CA, NM. One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit co
| Recall number | Z-2978-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, Inc., Waukegan, IL, United States |
| Recall initiated | 2017-04-12 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2019-08-05 |
| Distributed | CA, NM |
| Quantity | 15 kits |
| Reason classes | chemical contamination, labeling, sterility |
| Lot numbers | 17MB5499 |
| Model numbers | CDS920114F |
Product
Laparoscopy CDS
Reason for recall
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
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-2978-2018. 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.