Tracheostomy care kits: — Class I medical device recall Z-0561-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-01-03, distributed nationwide. The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use a
| Recall number | Z-0561-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-10-16 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Quantity | 620,735 kits |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10080196032761, 10080196032877, 10080196032914, 10080196503384, 10080196503391, 10080196503407 |
| Lot numbers | 6052203006, 6052203022, 6052204005, 6052204010, 6052204011, 6052205021, 6052205022, 6052205023, 6052205024, 6052205028, 6052206003, 6052206010, 6052206011, 6052206020, 6052206021, 6052207009, 6052207013, 6052207014, 6052207015, 6052207030, 6052208009, 6052208021, 6052208022, 6052208040, 6052209009, 6052209025, 6052209026, 6052209027, 6052210008, 6052210015, 6052210016, 6052210031, 6052210032, 6052211034, 6052212009, 6052212010, 6052212015, 6052212021, 6052212022, 6052212023 and 39 more |
| Model numbers | CC3T3030A, CC3T4691A, CC4681A, DYND40580, DYND4061030, DYND40622 |
Product
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile; (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.
Reason for recall
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0561-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.