Recall of Medline Medical Kits Containing Non-Sterile Alcohol Prep Pads

Source: FDA · United States

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Medline Industries, LP is recalling approximately 28,550 medical kits due to non-sterile alcohol prep pads contaminated with Paenibacillus phoenicis, posing potential health risks. The recall affects kits distributed nationwide in the US.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 13, 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Medline Industries, LP is recalling specific medical kits because they contain Webcol Large Alcohol Prep Pads that are non-sterile, following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Which Products Are Affected

The affected products are various Medline or Centurion medical convenience kits, including:

  • NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E
  • IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700
  • IV START KIT (Centurion), Medline Kit SKU IV8675
  • NEONATAL IV SECUREMENT KIT W/SHIELD (Centurion), Medline Kit SKU IVSSTK12
  • IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940
  • IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775 And additional lots as specified. A total of 28,550 kits are affected, with specific lot numbers such as 2025102390 for IV8310E and IVS1700, 2025110790 for IV8675, and others up to 2026012990. Distribution was US Nationwide. UDI/DI codes include 10653160293798 for individual IV8310E and 00653160293791 for cases, among others.

What You Should Do

The firm has initiated notifications via two or more methods, including email, fax, letter, press release, telephone, or visit. Consumers with affected kits should follow these notifications for instructions on returns or further actions.

Why This Matters

This recall highlights the importance of sterility in medical devices to prevent potential infections, affecting patient safety in healthcare settings and underscoring the need for rigorous quality checks in product manufacturing.

Source

FDA Recall Number: Z-2043-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling approximately 28,550 medical kits due to non-sterile alcohol prep pads contaminated with Paenibacillus phoenicis, posing potential health risks. The recall affects kits distributed nationwide in the US.
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.