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, LP is recalling 24,388 units of various medical procedure kits nationwide and worldwide due to catheter performance specification failures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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 an internal review found representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Which Products Are Affected
The recall covers 24,388 units of the following MEDLINE Medical Procedure Kits distributed nationwide in the US and to AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI:
- BR L&D PACK (SKU DYNJ47625B)
- GYN VAGINAL (SKU DYNJ912219)
- KIT MAJ VAG SET UP (SKU DYNJ907033B)
- MINOR VAG PACK (SKU DYNJ68663B)
- OB DELIVERY PACK (SKUs DYNJ14099F, DYNJ14099G)
- OB PACK (SKUs DYNJ03387B, DYNJ03387C, DYNJ53543B)
- RR-D/E PACK (SKUs DYNJ62645D, DYNJ62645F, DYNJ62645G)
- VAGINAL DELIVERY PACK (SKUs DYNJ04454K, DYNJ04454L)
- VAGINAL PACK (SKU DYNJ01830G)
Specific lot numbers and UDI/DI codes for each SKU are detailed in FDA recall Z-2501-2026. The recall is classified as Class II and remains ongoing.
What You Should Do
Consumers should check product lot numbers against the recall notice and follow instructions provided by Medline Industries, LP.
Why This Matters
The recall affects medical procedure kits used in labor, delivery, gynecological, and related procedures across the United States and multiple international markets.
Source
FDA recall number Z-2501-2026 (https://www.fda.gov)
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 (1,538 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.