Medline Industries Recalls General Closure Convenience Kits Over Sterility Assurance Concerns
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP is recalling 108 units of its General Closure Convenience Kits (Model DYKMBNDL200A) because equipment calibration issues may have compromised the sterility of the devices.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, medical-device) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific convenience kits used for general closures. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. Although the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices.
Which Products Are Affected
The recall affects the Medline Convenience Kits: KIT GENERAL CLOSURE, specifically Model Number: DYKMBNDL200A. A total of 108 units are included in this recall.
The affected products can be identified by the following codes:
- UDI-DI: 10195327240592 (each), 40195327240593 (case)
- Lot Numbers: 25HBD027, 25FBD161, 25EBN454, 25EBG142, 25EBE995, 25DBE771, 25CBB549, 25BBS071, 25BBB895, 24FBK537, 24CBK339, 24ABH890, 23KBA331, and 22KBD675.
The distribution of these products was nationwide across the United States and worldwide.
What You Should Do
Medline Industries notified affected customers via a formal letter. Facilities and healthcare providers should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided by Medline. For further information or to coordinate returns, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.
Why This Matters
The sterility of medical devices is critical for patient safety. If the sterility assurance level is compromised, there is an increased risk of infection or other adverse health consequences for patients undergoing procedures where these kits are used.
Source
Information provided by the FDA under recall number Z-1405-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category