Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz… — Class II medical device recall Z-2293-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-08-09, distributed nationwide. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
| Recall number | Z-2293-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 29,277 kits |
| Reason classes | labeling, sterility |
| Model numbers | DYNJRA0827A, DYNJRA0881, DYNJRA0949C, DYNJRA0961B, DYNJRA1498A, DYNJRA1603, DYNJRA1739A, DYNJRA1823, DYNJRA1837, DYNJRA1847, DYNJRA1864, DYNJRA1869, DYNJRA1878, DYNJRA1893, DYNJRA1900, DYNJRA1945, DYNJRA1975, DYNJRA1978, DYNJRA1978A, DYNJRA1998, DYNJRA2022, DYNJRA2027, DYNJRA2028, DYNJRA2040, DYNJRA2055 and 6 more |
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A; h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027; i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837; j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900; k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055; l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A; m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975; n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028; o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762; p. PAIN TRAY, Model Number: DYNJRA1603; q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560; r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040; s. PREP TRAY, Model Number: DYNJRA1498A; t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B; u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077; v. TAP BLOCK, Model Number: DYNJRA1823; w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044; x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040; y. ULTRASOUND TRAY, Model Number: DYNJRA2022; z. US TPI KIT, Model Number: DYNJRA1945
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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-2293-2023. 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.