Medline Kits: 1) SYR CONTROL 8ML ROTATING — Class II medical device recall Z-1843-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have be
| Recall number | Z-1843-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-25 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 198,210 units |
| UPC / GTIN / UDI-DI | 10884389676462, 10889942596225, 40884389676463, 40889942596226 |
| Lot numbers | 21ABS242, 21BBM369, 21DBO183, 21DBY321, 21FBC554, 21FBJ020, 21FBU555, 21KBN994, 21KBV737, 22ABI338, 22CBV056, 22DBT508, 22EBK614, 22IBH075, 22IBH622, 22IBU135, 22JBN943, 22LBO542, 22OBA220, 22OBG844, 23DBH886, 23DBO855, 23FBM361, 23HBF967, 23HBM037, 23HBM038, 23HBZ420, 23IBD522, 23KBQ419, 24BBB469, 24EBT832, 24EBT833, 24EBU578, 24EBV379, 24GBC953, 24GBK311, 24GBP361, 24GBQ243, 24GBV309, 24HBQ322 and 22 more |
| Model numbers | DNSC89369, DYNJSYR10C |
Product
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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-1843-2026. 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.