Medline Probe Cover Kits containing sterile Ultrasound Gel — Class II medical device recall Z-2162-2023
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-2162-2023 |
|---|---|
| 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 | 3,740,814 units |
| UPC / GTIN / UDI-DI | 10193489800999, 10195327118891, 10195327137885, 10195327219963, 10195327231514, 10195327240509, 10195327248659, 10195327250195, 10195327273163, 10195327288228, 10195327299125, 10195327300692, 10195327311018, 10195327313807, 10195327314613, 10195327318550, 10195327329709, 10195327336561, 10195327341961, 40193489800990, 40195327118892, 40195327137886, 40195327219964, 40195327231515, 40195327240500 and 13 more |
| Model numbers | DYNJ83105, DYNJ83251, DYNJ83508, DYNJ83656, DYNJ83696, DYNJ83746, DYNJ83815, DYNJ83918, DYNJ83936, DYNJ84040, DYNJ84190, DYNJ902507C, DYNJ902507D, DYNJ905151B, DYNJ906766B, DYNJ908249A, DYNJ909267, DYNJVB1000, SYNJ10303C |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C
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-2162-2023. 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.