DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-31 · Class II · Z-3058-2026
EventRecall classified
Effective2026-08-31
ClassificationClass II
On 2026-08-31 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT…. Recall Z-3058-2026. The firm initiated it on 2026-06-12. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3058-2026
- Classification
- Class II
- Classified on
- 2026-08-31
- Initiated on
- 2026-06-12
- Firm
- Medline Industries, LP
- Reason
- The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
- Product
- Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3058-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
513b65c0ae3c9bfe8ffcece4fdd95ae852dd2406b5feed5bbd898251f6ab1fb6- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)