Data Foundry

Medical device recalls 2020

Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30… — Class II medical device recall Z-1358-2020

Terminated recall by Medline Industries Inc, reported 2020-03-04, distributed in CA. The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle,

Recall numberZ-1358-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedline Industries Inc, Northfield, IL, United States
Recall initiated2020-01-21
Classified2020-02-25
Reported by FDA2020-03-04
Terminated2023-01-12
DistributedCA
Quantity122
Reason classessterility
UPC / GTIN / UDI-DI10888277056350
Lot numbers20AKA927
Model numbersCDS984543B
Expiration dates2020-09-30

Product

Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

Reason for recall

The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

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-1358-2020. 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.