UnratedMedical device recall · FDA · Published April 6, 2023
Cardinal Health Presource Kit Recall: Sterility Risk in Laparoscopy Packs
Cardinal Health recalls SMA21LPUHJ GYN Laparoscopy Packs due to potential lack of sterility assurance. Affected kits may pose infection risks during surgery.
“Cardinal Health Presource Kit Recall: Sterility Risk in Laparoscopy Packs.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58601-cardinal-health-presource-kit-recall-sterility-risk-in-laparoscopy-packs. Based on FDA recall #Z-1690-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1690-2023%22&limit=1).
Cardinal Health 200, LLC recalled one Presource Kit (Catalog Number SMA21LPUHJ) distributed to Georgia because it was inadvertently released without sterility assurance, according to the FDA on April 6, 2023.
The FDA stated the hazard is that the kit was inadvertently released for distribution without sterility assurance.
Context
GovInfoNow's records show Cardinal Health 200, LLC has had 58 other recalls since June 27, 2017. Other recent recalls of similar products include Presource Gyn Laparoscopy Kits May Leak Fluids During Use (Aug. 18, 2026), Cardinal Health Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (Aug. 10, 2026), and Cardinal Health Presource Packs with Contaminated Wipes Risk Skin Irritation (July 29, 2026). Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (Jan. 7, 2026) and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (Jan. 7, 2026).
How to tell if you have this one
Check for the model number SMA21LPUHJ on the kit. The kit was sold with lot number 019693 and is used for laparoscopic surgery.
Brand
Cardinal Health
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Look for the model number SMA21LPUHJ on the kit label.
Where it went and when
Where it was distributed
Distributed in Georgia.
Listed by the agency
Not listed
FDA distribution: “Distribution in the US to Georgia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1690-2023 (April 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1690-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.