Medline Recalls Convenience GI Kits Over Potential Sterility Assurance Issues
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Medline Industries, LP is recalling 23,238 GI kits because calibration issues with sterilization equipment may have compromised the sterility of the medical devices.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 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, MedicalDevices.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific convenience kits used in gastrointestinal (GI) procedures. The company identified calibration issues with the equipment used to sterilize and package these devices. Although the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected units.
Which Products Are Affected
The recall involves approximately 23,238 units distributed nationwide in the United States and worldwide. The 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
- UDI-DI: 10193489258684 (each), 40193489258685 (case)
- Lot Numbers: 23KMC417, 23IMF495, 23HMG566, 23GMF416, 23GMC067, 23EMF635, 23CMG332, 23CMC558, 23CMB706, 23BMC768, 22LMF786, 22JMC784, 22HMD809, 22GMH729, 22FMH954, 22FMD365, 22EMI534, 22EMH737, 21KBP287, 21IBL687, 21CBH946, 21CBH534, 21BBK795.
What You Should Do
Medline Industries, LP notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. If you possess these products, follow the instructions provided in the firm's notification letter regarding the return or disposal of the affected kits.
Why This Matters
This recall is significant because medical devices used in GI procedures must maintain a specific sterility assurance level to prevent patient infections. A failure in the sterilization process poses a potential health risk to patients undergoing medical interventions.
Source
Information provided by the FDA. Recall Number: Z-1396-2026.
Original source: FDA Official Notice ↗
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