Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A
Why it was recalled
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-2177-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Northfield, IL
- Recall initiated
- 2023-05-18
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2177-2023 · Source: openFDA enforcement.