Lower riskMedical device recall · FDA · Published December 1, 2021
Medline Premier Rotaclone Rx Only: Risk of Incorrect Storage
Medline Industries recalls Premier Rotaclone (Rx only) due to potential improper storage in temperature-controlled settings instead of refrigeration. This may affect product safety.
“Medline Premier Rotaclone Rx Only: Risk of Incorrect Storage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61485-medline-premier-rotaclone-rx-only-risk-of-incorrect-storage. Based on FDA recall #Z-0552-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2022%22&limit=1).
The FDA announced on Dec. 1, 2021, that Medline Industries LP recalled Premier Rotaclone devices due to improper storage. The hazard arises from storing the product in a temperature-controlled setting instead of refrigeration. GovInfoNow's records show this voluntary Class II recall involved 34 units distributed nationwide.
How to tell if you have it
Brand: Medline Industries
Product: Premier Rotaclone, Rx only
Model Number: RID696004
Lot Number: 696004N116
Expiration Date: 01/12/2023
The hazard
The product was stored incorrectly in a temperature-controlled setting instead of refrigeration, according to the FDA. The agency described this storage error as the primary hazard for the recalled devices.
Context
GovInfoNow's records show Medline Industries LP has issued 119 other recalls since Oct. 22, 2021. Recent recalls include light failures in intubation trays reported on July 25, 2025, and incorrect labeling risks in Foley Tray Kits noted on July 23, 2025. Other recent recalls of similar products include Medline Convenience Kits Recall: Temperature Probes May Have Distribution Error (May 28, 2026) and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).
How to tell if you have this one
Check for model number RID696004 and lot number 696004N116 on the product label. The expiration date is 01/12/2023. This product is for prescription use only.
Brand
Medline Industries
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Storage Conditions
Ensure the product is stored in a refrigerator, not a temperature-controlled setting.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California and Massachusetts.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Massachusetts.
Recall timeline
FDA terminated this recall 14 months 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-0552-2022 (December 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0552-2022 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.