Medline Industries Recalls Drape Pack-Choice Convenience Kits Over Sterility Concerns
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Medline Industries, LP is recalling 72 units of its Drape Pack-Choice convenience kits because calibration issues with sterilization equipment may have compromised the products' sterility.
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, medical-device.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific Medline Convenience Kits after identifying calibration issues with the equipment used to sterilize and package the devices. Although the products were exposed to validated sterilization and packaging cycles, the firm determined that the calibration errors have the potential to impact the sterility assurance level (SAL) of the recalled units.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Medline Convenience Kits: DRAPE PACK-CHOICE
- Model Number: DYNJ63118A
- Lot Number: 25ABV005
- UDI-DI: 10195327644291 (each); 40195327644292 (case)
- Quantity: 72 units
- Recall Number: Z-1406-2026
These units were distributed nationwide within the United States and through worldwide distribution channels.
What You Should Do
Healthcare facilities and distributors should immediately check their inventory for the affected lot number (25ABV005). Affected products should be quarantined and should not be used in clinical settings. Medline Industries began notifying customers of the issue via letter on January 7, 2026. For information regarding the return or replacement of these kits, contact Medline Industries, LP at their headquarters in Northfield, Illinois.
Why This Matters
Compromised sterility in medical devices like drape packs can lead to a significantly increased risk of infection for patients during surgical or medical procedures. Maintaining a high sterility assurance level is critical for patient safety.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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