Class II FDA device recall · Z-2169-2023

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) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;

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 CDS840214Q, UDI/DI (EA) 10195327289904, UDI/DI (CS) 40195327289905;  b) Model Number DYNDA2418, UDI/DI (EA) 10193489378214, UDI/DI (CS) 40193489378215;  c) Model Number DYNJ0365463J, UDI/DI (EA) 10193489783872, UDI/DI (CS) 40193489783873;  d) Model Number DYNJ24459P, UDI/DI (EA) 10193489355345, UDI/DI (CS) 40193489355346;  e) Model Number DYNJ40629B, UDI/DI (EA) 10888277778696, UDI/DI (CS) 40888277778697;  f) Model Number DYNJ44210B, UDI/DI (EA) 10193489306859, UDI/DI (CS) 40193489306850;  g) Model Number DYNJ47716C, UDI/DI (EA) 10195327355296, UDI/DI (CS) 40195327355297;  h) Model Number DYNJ48520, UDI/DI (EA) 10888277903463, UDI/DI (CS) 40888277903464;  i) Model Number DYNJ53059A, UDI/DI (EA) 10889942415113, UDI/DI (CS) 40889942415114;  j) Model Number DYNJ59813, UDI/DI (EA) 10888277786455, UDI/DI (CS) 40888277786456;  k) Model Number DYNJ61747C, UDI/DI (EA) 10193489365030, UDI/DI (CS) 40193489365031;  l) Model Number DYNJ68027A, UDI/DI (EA) 10195327351144, UDI/DI (CS) 40195327351145;  m) Model Number DYNJ81410B, UDI/DI (EA) 10195327320829, UDI/DI (CS) 40195327320820;  n) Model Number DYNJ82517, UDI/DI (EA) 10195327198640, UDI/DI (CS) 40195327198641;  o) Model Number DYNJ83966, UDI/DI (EA) 10195327320423, UDI/DI (CS) 40195327320424;  p) Model Number DYNJ906915, UDI/DI (EA) 10193489280371, UDI/DI (CS) 40193489280372;  q) Model Number DYNJ908046C, UDI/DI (EA) 10195327313494, UDI/DI (CS) 40195327313495;  r) Model Number PHS751646C, UDI/DI (EA) 10889942245352, UDI/DI (CS) 40889942245353;  s) Model Number PHS751646D, UDI/DI (EA) 10195327196806, UDI/DI (CS) 40195327196807;

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-2169-2023
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-2169-2023 · Source: openFDA enforcement.