Medline Robotic Hysterectomy Kits Recall Over Endotoxin Levels
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Medline Industries is recalling 632 medical procedure kits due to higher-than-expected endotoxin levels in the 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 an internal review identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that the in-market product may be out-of-specification for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits containing Medline Neuro Sponges, specifically:
- ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B, with UDI/DI each 10193489251630, UDI/DI case 40193489251631, and Lot Numbers: 21KBM212, 21IBT678, 21GBF973, 21EBR775, 21DBH715, 21BBI962.
- ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C, with UDI/DI each 10195327040079, UDI/DI case 40195327040070, and Lot Numbers: 22HBO534, 22FBY086, 22FBG752, 22CBY116, 22ABS155, 21LBF114.
- ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D, with UDI/DI each 10195327275938, UDI/DI case 40195327275939, and Lot Numbers: 23JBN926, 23FBE547, 23EBI633, 23DBA946, 23CBD209, 23ABH377. A total of 632 kits are affected, with worldwide distribution.
What You Should Do
Consumers should contact Medline Industries, LP for instructions, as the recall was initiated through notifications such as email, fax, letter, press release, telephone, or visit. Follow the firm's guidance for returning or handling the affected products.
Why This Matters
This recall involves medical devices that could pose health risks due to potential endotoxin contamination, affecting healthcare procedures worldwide and emphasizing the need for quality control in medical supplies.
Source
FDA Recall Number Z-2035-2026. For more information, refer to the FDA's enforcement report at https://www.fda.gov (attribution to FDA).
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,747 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.