Medline Medical Procedure Kits Recall

Source: FDA · United States

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 44,656 units of various medical procedure kits 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, medical-devices.

What Happened

Medline Industries, LP initiated a voluntary recall of certain MEDLINE Medical Procedure Kits 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 44,656 units of MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, and others. Affected products include numerous SKUs such as DYNJ905924B, DYNJ905924D, DYNJ905924C, DYNJ906047A, DYNJ906047C, DYNJ901133A, DYNJ909989, DYNJ53820A, DYNJ68426, and many additional SKUs with specific lot numbers detailed in the recall. Distribution was nationwide in the US and to countries including AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, and VI. The recall number is Z-2503-2026 and it is classified as Class II.

What You Should Do

Consumers and facilities should review the full list of affected products and lot numbers in the recall documents. Contact Medline Industries, LP for return or refund instructions.

Why This Matters

The recall addresses potential device performance issues in medical procedure kits distributed worldwide.

Source

FDA Recall Z-2503-2026 - Medline Industries, LP, Northfield, IL

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 44,656 units of various medical procedure kits due to catheter performance specification failures.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.