FDA Recalls high

Medline Industries Recalls 3,561 Medical Convenience Kits Over Sterility Concerns

Source: FDA · United States

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Medline Industries, LP has voluntarily recalled several types of medical convenience kits due to calibration issues that may have compromised the sterility of the devices.

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

This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP has initiated a voluntary recall of various medical convenience kits after identifying calibration issues with equipment used during the sterilization and packaging process. While the affected products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the devices. This recall has been classified as a Class II recall by the FDA.

Which Products Are Affected

A total of 3,561 units are included in this recall. The affected products were distributed worldwide and nationwide across the United States. The recall involves the following 10 kit types and specific model numbers:

  1. ENDO KIT W/SYRINGE: Model DYKE1743 (Lots: 23KBQ544, 23JBO193)
  2. BGMC ANGIOGRAPHY PACK-LF: Model DYNJ0800934D (Lots: 21EBQ851, 21DBA951, 21BKA527, 21AKB217)
  3. GENERAL ENDO PACK-LF: Model DYNJ0842873J (Lot: 21ADA204)
  4. OR ANGIO PACK-LF: Model DYNJ43415C (Lots: 22EBI127, 22EBF322, 22CBF108)
  5. ANGIO PACK II: Model DYNJ44066A (Lots: 22CLA012, 22BLA508, 21KLA332, 21HLA812, 21CLA325)
  6. SOUTH CATH LAB PACK: Model DYNJ61978A (Lot: 20LDB953)
  7. BIOPSY ANGIO TRAY ALEX: Model DYNJ63542B (Lot: 23DBP359)
  8. SURGICAL TECH KIT: Model DYNJ907452 (Lot: 20LBW791)
  9. ANGIOGRAPHY PACK: Model DYNJC2371G (Lot: 23BBT999)
  10. SPECTRUM HEALTH CATH PACK-LF: Model PHS853965G (Lot: 21ADA067)

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information, consumers may contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Sterility is critical for medical devices used in surgical and clinical settings. If the sterility assurance level is compromised, there is an increased risk of patient infection or other serious health complications during medical procedures.

Source

FDA Recall Notice Z-1388-2026 - Medline Industries, LP

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 has voluntarily recalled several types of medical convenience kits due to calibration issues that may have compromised the sterility of the devices.
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 "high" severity. Take precautions and monitor for updates.
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.

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