Medline Probe Cover Kits containing sterile Ultrasound Gel — Class II medical device recall Z-2158-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-07-26, distributed nationwide. Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
| Recall number | Z-2158-2023 |
|---|---|
| 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 | 2023-05-18 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 23,938 units |
| UPC / GTIN / UDI-DI | 10193489211511, 10193489217667, 10193489264739, 10193489299816, 10193489367645, 10193489773095, 10193489810479, 10193489862973, 10193489891690, 10888277795037, 10888277900172, 10889942084630, 10889942225118, 10889942720927, 10889942937349, 40193489211512, 40193489217668, 40193489264730, 40193489299817, 40193489367646, 40193489773096, 40193489810470, 40193489862974, 40193489891691, 40888277795038 and 5 more |
| Model numbers | DYNJ0134147D, DYNJ0703127A, DYNJ42367B, DYNJ47338, DYNJ51107B, DYNJRA0656A, DYNJRA1220, DYNJRA1287A, DYNJRA1543, DYNJRA1571, DYNJRA1604, DYNJRA1635A, DYNJRA1773, PAIN1182, PAIN1622A |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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-2158-2023. 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.