Medline Industries Recalls 3,561 Medical Convenience Kits Over Sterility Concerns
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Medline Industries, LP has voluntarily recalled several types of medical convenience kits due to calibration issues that 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 April 6, 2026 and geographically references United States. Its severity classification of "high" 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 various medical convenience kits after identifying calibration issues with equipment used during the sterilization and packaging process. While the affected products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the devices. This recall has been classified as a Class II recall by the FDA.
Which Products Are Affected
A total of 3,561 units are included in this recall. The affected products were distributed worldwide and nationwide across the United States. The recall involves the following 10 kit types and specific model numbers:
- ENDO KIT W/SYRINGE: Model DYKE1743 (Lots: 23KBQ544, 23JBO193)
- BGMC ANGIOGRAPHY PACK-LF: Model DYNJ0800934D (Lots: 21EBQ851, 21DBA951, 21BKA527, 21AKB217)
- GENERAL ENDO PACK-LF: Model DYNJ0842873J (Lot: 21ADA204)
- OR ANGIO PACK-LF: Model DYNJ43415C (Lots: 22EBI127, 22EBF322, 22CBF108)
- ANGIO PACK II: Model DYNJ44066A (Lots: 22CLA012, 22BLA508, 21KLA332, 21HLA812, 21CLA325)
- SOUTH CATH LAB PACK: Model DYNJ61978A (Lot: 20LDB953)
- BIOPSY ANGIO TRAY ALEX: Model DYNJ63542B (Lot: 23DBP359)
- SURGICAL TECH KIT: Model DYNJ907452 (Lot: 20LBW791)
- ANGIOGRAPHY PACK: Model DYNJC2371G (Lot: 23BBT999)
- SPECTRUM HEALTH CATH PACK-LF: Model PHS853965G (Lot: 21ADA067)
What You Should Do
Medline Industries 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. Affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information, consumers may contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
Sterility is critical for medical devices used in surgical and clinical settings. If the sterility assurance level is compromised, there is an increased risk of patient infection or other serious health complications during medical procedures.
Source
FDA Recall Notice Z-1388-2026 - Medline Industries, LP
Original source: FDA Official Notice ↗
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