Lower risk Medical device recall · FDA · Published January 28, 2019

LivaNova S5 System: Incorrect Labeling Risk

LivaNova recalls S5 systems with incorrect manufacturing date labels. Some devices show dates in yy-mm-dd format instead of yyyy-mm-dd. Affected units may have labeling errors that could cause confusion during use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1119-2020Medical device LivaNova ›

Lower-risk recall

Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.

Take action

Contact the company

Recalling firmLivaNova USA Inc.14401 W 65th Way · Arvada, CO 80004-3503

✎ GovInfoNow plain-language explainer

LivaNova is recalling certain S5 systems due to incorrect labeling on the manufacturing date. This error could lead to confusion about when the device was made, potentially affecting proper use during medical procedures. Read more at govinfonow.com/recall/69077-livanova-s5-system-incorrect-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69077-livanova-s5-system-incorrect-labeling-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1119-2020

Cite this page

“LivaNova S5 System: Incorrect Labeling Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69077-livanova-s5-system-incorrect-labeling-risk. Based on FDA recall #Z-1119-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1119-2020%22&limit=1).

The FDA announced on 2019-01-28 that LivaNova USA, Inc. is voluntarily recalling five Datapad devices due to incorrect labeling. The manufacturer said the manufacturing date format was wrong on some units.

How to tell if you have it

Brand: LivaNova
Product: SORIN CONNECT DPIII KOMPL. S5, Catalog Number 24-90-80, Serial Numbers 17BQC0247, 17BQC0249, 17BQC0250, 17BQC0258
Product: DATAPADIII WITHOUT SOFTWARE, Catalog Number 24-90-87, Serial Number 17BQC0257
UPC: 04033817901594

The hazard

According to the FDA, some Datapad devices contained incorrect labels where the manufacturing date in the production identifier was wrong. The manufacturing date on the unique device identifier label was formatted as yy-mm-dd instead of yyyy-mm-dd.

Context

GovInfoNow's records show LivaNova USA, Inc. has had 18 other recalls since 2018-01-24. Recent LivaNova recalls include the 2025-01-03 SenTiva DUO VNS Therapy Generator recall for risk of stopping therapy and the 2024-12-12 SenTiva VNS Generator recall for risk of stopped seizure control. Other recent recalls of similar products include the Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (2026-05-13), Omnicell i.v.Station Label Stock Recall (2026-03-25), and Baxter Healthcare PRO+ 40" MRS SURFACE Mattress Recall (2026-08-18).

How to tell if you have this one

Check for the model SORIN CONNECT DPIII KOMPL. S5 with serial numbers starting with 17BQC0247 to 17BQC0258. The device may have a manufacturing date label showing a two-digit year instead of four digits.

Brand
LivaNova
Product
LivaNova USA Inc. recalls LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Labels
Look for the manufacturing date label on the device that shows a two-digit year (e.g., 2024) instead of four digits (e.g., 2024).

Where it went and when

Where it was distributed

Distributed in California and New Jersey.

FDA distribution: “US: NJ and CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, New Jersey.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Jan 28, 2019Firm started the recall
Feb 10, 2020FDA classified it Class III
Feb 19, 2020Published in FDA’s Enforcement Report
Jan 31, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69077-livanova-s5-system-incorrect-labeling-risk">LivaNova S5 System: Incorrect Labeling Risk (GovInfoNow)</a>

Where this comes from

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-1119-2020 (January 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1119-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.