Medline Industries Recalls Lithotomy Packs Due to Potential Sterility Concerns
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Medline Industries, LP has voluntarily recalled 808 units of Lithotomy Packs after identifying equipment calibration issues that may compromise 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, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific Lithotomy Packs included in its convenience kits. The company identified calibration issues with the equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the devices.
Which Products Are Affected
The recall affects 808 units distributed worldwide and nationwide across the United States. The following Medline Convenience Kits are included:
LITHOTOMY PACK (Model Number: DYNJ83185)
- UDI-DI: 10195327247058 (each), 40195327247059 (case)
- Lot Numbers: 23FDC392, 23CDB552, 23CDA474, 22LDA486
LITHOTOMY PACK (Model Number: DYNJ83185A)
- UDI-DI: 10195327468606 (each), 40195327468607 (case)
- Lot Numbers: 24KDB955, 24IDB525, 24GDB922, 24FDB302, 24EDB468, 24DDB769, 24CDB829, 24CDB327, 24CDA984, 23HDB637
What You Should Do
Medline began notifying customers of the issue via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Any affected products should be quarantined and handled according to the instructions provided in Medline's notification. For additional information regarding returns or the recall process, contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
A compromised sterility assurance level in surgical equipment poses a risk of infection to patients. This Class II recall indicates that while the hazard may not be immediately life-threatening, the use of these products could lead to temporary or medically reversible adverse health consequences.
Source
Information provided by the FDA under Recall Number Z-1398-2026.
Original source: FDA Official Notice ↗
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