Medline Industries Recalls Over 4,700 Convenience Kits Due to Sterility Concerns
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Medline Industries, LP has issued a voluntary recall for 4,757 convenience kits, including surgical and urology packs, due to equipment calibration issues that may affect product sterility.
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.
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What Happened
Medline Industries, LP has initiated a voluntary Class II recall of various Medline Convenience Kits due to potential compromises in sterility. The company identified calibration issues with the equipment used to sterilize and package the devices. While all products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected products.
Which Products Are Affected
A total of 4,757 units are affected by this recall. The products were distributed nationwide in the United States and worldwide. Affected items include 58 different kit configurations, such as:
- Plastic Bins with Misc Kits: Model ACC010499
- Urology Urethroplasty Kits: Model DYKMBNDL117C
- Plastic Surgery Kits (Abdominoplasty, Tissue Expansion, Rotational Flap): Models DYKMBNDL158, DYKMBNDL170 (A/B), DYKMBNDL182 (A/B), DYKMBNDL183 (A/B)
- Breast Procedure Packs (Reduction, Augmentation, Reconstruction): Models DYKMBNDL46, DYKMBNDL69 (A/B), DYKMBNDL78 (A/B), DYKMBNDL84 (C), DYNJ36469I, DYNJ44852K/M, DYNJ50957G, DYNJ55358G, DYNJ60210A, DYNJ69351, DYNJ83788, DYNJ83950A/B, DYNJ87444, DYNJT3283, DYNJT3417
- Facial and ENT Packs: Models DYKMBNDL34A, DYNJ0854650J, DYNJ38988J, DYNJ68844A, DYNJ907874A, DYNJ910462
- Major Surgery and Specialty Packs: Models DYNJ0785310G, DYNJ56737A, DYNJ64927F, DYNJ83884B, DYNJ86165, DYNJ86816, DYNJ902005I, DYNJ902558G, DYNJ903555D/F, DYNJ903849C, DYNJ907847A, PHS806973G
Specific lot numbers and UDI-DI codes for each model are listed in the official FDA enforcement report under recall number Z-1397-2026.
What You Should Do
Medline Industries, LP notified affected customers via letter starting January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Consumers or providers with questions regarding the return or replacement of these kits should contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
When the sterility assurance level of medical devices is compromised, there is an increased risk of patient infection or other serious health complications during surgical or clinical procedures.
Source
Recall initiated by Medline Industries, LP; documented by the FDA.
Original source: FDA Official Notice ↗
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