Lower riskMedical device recall · FDA · Published January 21, 2020
Medline CDS984543B Sterile Pack Recall: Risk of Contaminated Medical Devices
Medline recalls CDS984543B sterile packs due to incomplete sterilization. These packs may contain contaminants, risking infection during medical procedures. Affected units have specific lot and expiration dates.
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.
Take action
Contact the company
📍Recalling firmMedline Industries IncThree Lakes Drive · Northfield, IL 60093
“Medline CDS984543B Sterile Pack Recall: Risk of Contaminated Medical Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65964-medline-cds984543b-sterile-pack-recall-risk-of-contaminated-medical-devices. Based on FDA recall #Z-1358-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2020%22&limit=1).
The FDA announced on Jan. 21, 2020, that Medline Industries Inc voluntarily recalled its ROBOTIC-LF Complete Delivery System due to potential sterility failures. The agency issued recall number Z-1358-2020 for the affected medical device.
How to tell if you have it
Brand: Medline
Product: ROBOTIC-LF REF CDS984543B
Lot code: 20AKA927
Expiration date: 2020-09-30
GTIN/UPC: (01)10888277056350 / 10888277056350
The hazard
The sterile pack inside the Complete Delivery System did not go through a complete sterilization cycle, so sterility cannot be guaranteed. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Medline Industries Inc has had 48 other recalls on record since Sept. 25, 2015. Other recent recalls of similar products include the Jan. 7, 2026, Convenience Kits recall for contaminated sterile product risk and the June 12, 2026, Convenience Kits recall for sterile packaging breach.
How to tell if you have this one
Check for the model CDS984543B, lot number 20AKA927, and expiration date 2020-09-30 on the packaging. The GTIN number is 0110888277056350.
Brand
Medline
Product
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103
Recall number
Product, codes & lots
Z-1357-2020
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180; REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
Z-1358-2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350; REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model CDS984543B, lot number 20AKA927, and expiration date 2020-09-30 on the packaging.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1358-2020 (January 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1358-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.