Medline Surgical Packs Recall Issued by FDA
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Medline Industries, LP is recalling 193,157 units of surgical packs due to potential sterility assurance issues from equipment calibration problems.
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 initiated a voluntary recall after identifying calibration issues with equipment used to sterilize and package the devices. All products underwent validated sterilization cycles, but the calibration problems may affect the sterility assurance level (SAL).
Which Products Are Affected
The recall covers two Medline Surgical Packs distributed nationwide in the United States and worldwide:
- PACK,UNIVERSAL,ULTRAGARD,5/CS (Model Number: DYNJP1050UG), UDI-DI: 10080196573509 (each), 40080196573500 (case), multiple lots including 72525030011, 72525050004, 72525100025, 72525100068, 72525020012, 72525040038, 72525060015, 72525060041, 72525080004, 72525080039, 72519120082, 72519120084, 72519120097, 72520020055, 72520030039, 72520030064, 72520030074, 72520050047, 72520060018, 72520060019, 72520070016, 72520080003, 72520080004, 72520080059, 72520100068, 72520120003, 72520120004, 72521040001, 72521050060, 72521050064, 72521050167, 72521060070, 72521070019, 72521070099, 72521080017, 72521090001, 72521090015, 72521100005, 72521100033, 72521110009, 72521110016, 72521120009, 72521120031, 72522010013, 72522020010, 72522030020, 72522040019, 72522050012, 72522050015, 72522060019, 72522060052, 72522070003, 72522080008, 72522110004, 72522110040, 72522120006, 72523100020, 72523100063, 72523110004, 72523120076, 72524010036, 72524010087, 72524030056, 72524040002, 72524050034, 72524060001, 72524060034, 72524060098, 72524070001, 72524080004, 72524090003, 72524090078, 72524100004, 72524100099, 72524110013, 72524120003, 72525010001
- PACK,SHOULDER,DRAPE,POUCH,10/CS (Model Number: DYNJP8401), UDI-DI: 10080196740710 (each), 40080196740711 (case), Lot Number: 72521080034 Total affected: 193157 units. Recall Number: Z-2130-2026. Classification: Class II. Recall initiation date: January 7, 2026.
What You Should Do
Consumers and healthcare facilities should check product lots against the recalled list and follow guidance from the recalling firm regarding the affected devices.
Why This Matters
The potential impact on sterility assurance level could affect the safety of surgical procedures using these packs.
Source
FDA recall Z-2130-2026, Medline Industries, LP, Northfield, IL.
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 (2,233 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.