Medline Convenience Kits Recall for Sterility Issue
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Medline Industries is recalling 23,238 units of two convenience kits due to potential sterility assurance level concerns from equipment calibration issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of certain convenience kits after identifying calibration issues with sterilization equipment that could impact the sterility assurance level (SAL) of the products.
Which Products Are Affected
The recall covers 23,238 units distributed nationwide in the United States and worldwide. Affected products include:
- BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B, UDI-DI: 10193489760781 (each), 40193489760782 (case), Lot Number: 22IBV801
- GI LAB OTHER ENDO KIT, Model Number: DYKE1721, with the following lot numbers and UDI-DIs (10193489258684 each / 40193489258685 case): 21BBK795, 21CBH534, 21CBH946, 21IBL687, 21KBP287, 22EMH737, 22EMI534, 22FMD365, 22FMH954, 22GMH729, 22HMD809, 22JMC784, 22LMF786, 23BMC768, 23CMB706, 23CMC558, 23CMG332, 23EMF635, 23GMC067, 23GMF416, 23HMG566, 23IMF495, 23KMC417
Recall number: Z-2117-2026. Classification: Class II. Recall initiation date: January 7, 2026.
What You Should Do
Consumers and healthcare facilities should contact Medline Industries, LP for further information regarding the recalled products.
Why This Matters
The calibration issues have the potential to affect the sterility of the devices, which are used in gastrointestinal procedures.
Source
FDA Enforcement Report, recall number Z-2117-2026 (https://www.fda.gov)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,364 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.