Medline Medical Procedure Kits Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries is recalling 3290 medical procedure kits due to higher-than-expected endotoxin levels in included neuro sponges, potentially affecting product safety.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 13, 2026 and geographically references Worldwide. 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 is recalling certain medical procedure kits because of higher-than-expected endotoxin levels on the included Medline Neuro Sponges, as identified during an internal review.
Which Products Are Affected
The affected products are various Medline medical procedure kits, including: 1. CATARACT PACK (SKU DYNJ48725A), 2. OCULAR PACK (SKU DYNJ64138B), 3. OCULOPLASTY PACK (SKU DYNJ64572A), 4. OCULOPLASTY PACK (SKU DYNJ64572B), 5. MICROSURGERY PACK (SKU DYNJ67284A), 6. BASIC EYE PACK (SKU DYNJ81411A), 7. SMR SINUS PACK (SKU DYNJ84478), 8. FESS/SEPTO PACK (SKU DYNJ85025), 9. PLASTIC EYE PACK (SKU DYNJ89030), 10. NEURO (SKU DYNJ902935K), 11. OCULAR (SKU DYNJ909065), and 12. OCULAR (SKU DYNJ909065A). A total of 3290 kits are affected, distributed worldwide, with specific lot numbers such as 24IMG757 for DYNJ48725A, 22FME241 for DYNJ64138B, and others as detailed in the FDA notice.
What You Should Do
Consumers should stop using the affected kits immediately and contact Medline Industries, LP for instructions on returns or refunds. The firm notified customers via email, fax, letter, press release, telephone, or visit.
Why This Matters
This recall highlights potential risks from endotoxin contamination in medical devices, which could lead to adverse health effects, underscoring the need for strict quality standards in healthcare products.
Source
FDA Recall Number: Z-2037-2026. For more information, refer to the FDA website at https://www.fda.gov (attribution to FDA enforcement report).
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 (1,549 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.