MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and… — Class I medical device recall Z-1091-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-03-06, distributed nationwide. Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse
| Recall number | Z-1091-2024 |
|---|---|
| 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 | 2023-11-15 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Quantity | 2,683,387 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489866124, 10195327391409, 10888277204799, 10889942131150, 40193489866125, 40195327391400, 40888277204790, 40889942131151 |
| Lot numbers | 2022040690, 2022052390, 2022102090, 2023011790, 23ABA019, 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBD895, 23EBD896, 23EBD897, 23EBM580, 23EBM582, 23GBQ880, 23HBU078, 23HBV368, 23JBP946 |
| Model numbers | DYNDA1482, DYNDA1893A, DYNDJ1057A, DYNDJ1129 |
Product
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
Reason for recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
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-1091-2024. 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.