Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz… — Class II medical device recall Z-2333-2023
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-2333-2023 |
|---|---|
| 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 | 7,462 kits |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00019348986167, 00019348991666, 00019532702351, 00019532717379 |
| Model numbers | DYNJ0752001K, DYNJ0771979C, DYNJ60009B, DYNJ60009C, DYNJ63257B, DYNJ64027A, DYNJ64027B, DYNJ902540N, DYNJ904250G, DYNJ904254G, DYNJ904254I, DYNJ904343D, DYNJ904343F, DYNJ905824F, DYNJ905824G, DYNJ905824I, DYNJ905826G, DYNJ906578D, DYNJ906578F, DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F, DYNJ906616A, DYNJ906616B and 4 more |
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;
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-2333-2023. 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.