Medline Industries Recalls 4,853 Convenience Kits Over Sterilization Calibration Issues
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Medline Industries, LP is recalling nearly 5,000 medical convenience kits, including ophthalmic and surgical packs, due to equipment issues that may affect product sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 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 has initiated a voluntary Class II recall for various Medline Convenience Kits due to potential sterility concerns. The company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected units.
Which Products Are Affected
The recall affects 4,853 units distributed nationwide in the United States and worldwide. Affected products include 35 different kit configurations with various model numbers and lot numbers. Key models include:
- Ophthalmic Kits: Models DYKMBNDL104, DYKMBNDL104A, DYKMBNDL159, DYKMBNDL180, DYKMBNDL42, DYKMBNDL98, DYKMBNDL98A, DYKMBNDL98B.
- Surgical Packs: Models DYNJ17219C (Minor Eye), DYNJ38791M (Peds Eye/Muscle), DYNJ41207C (Eye Pack), DYNJ42043I (Ophthalmic), DYNJ44852J (Breast Reconstruction), DYNJ45585C (Custom Eye), DYNJ47859B/C (Eye Plastic), DYNJ53019A (Cataract), DYNJ54869A (Cataract), DYNJ55280B (Vitrectomy), DYNJ61779C (NDNW-Eye), DYNJ62306 (Eye PK), DYNJ64220 (Vitrectomy), DYNJ65808C (OSC Breast), DYNJ67973A (Mills Cataract), DYNJ68367B (Eye Pack), DYNJ68875D/F/G (Cataract), DYNJ902256C (Ophtho Plastic), DYNJ907495 (Retinal), DYNJ909924 (Cataract), DYNJ909925 (Combo Eye), and DYNJ909929 (Vitrectomy).
- Oncology Kits: Models DYKMBNDL43B (Surg Onc Port Insertion) and DYKMBNDL84B (Surg Onc Excision Breast).
Specific lot numbers range from 20XBF509 to 25EBG033. The recall number is Z-1420-2026.
What You Should Do
Medline Industries, LP notified affected customers via letter starting on January 7, 2026. Healthcare providers and facilities should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and not used in clinical settings. For information regarding returns or replacements, contact Medline Industries, LP at their headquarters at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall is classified as Class II, indicating that the use of these potentially non-sterile medical kits could cause temporary or medically reversible adverse health consequences, such as post-surgical infections. Maintaining a high Sterility Assurance Level is critical for patient safety during ophthalmic and surgical procedures.
Source
Recall information provided by the FDA. Event ID: 98329.
Original source: FDA Official Notice ↗
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